legislation and biological control of arthropods ... and biological control: challenges and...

_________________________________ Legislation and Biological Control: Challenges and Opportunities

Second International Symposium on Biological Control of Arthropods

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SESSION 14 INTRODUCTION: LEGISLATION ANDBIOLOGICAL CONTROL OF ARTHROPODS:

CHALLENGES AND OPPORTUNITIES

Barbara I. P. BARRATT1 and Ulrich KUHLMANN2

1AgResearch InvermayPrivate Bag 50034

Mosgiel, New [email protected]

2CABI Bioscience Switzerland CentreRue des Grillons 1

2800 Delemont, Switzerland

SESSION 14 INTRODUCTION

Regulation of biological control agent introduction in most countries is achieved by legisla-tion. Provisions within such legislation vary considerably between countries. Recent globalconcerns about globalization, and adverse environmental and economic impacts frombiosecurity incursions, has in some cases, resulted in reviews of existing, or the enactment ofnew legislation. In this session we will see how some countries, particularly those who arekey users of biological control technology, have developed regulatory frameworks for bio-logical control. These include Europe, the United States (including details of the regulatoryprocess in Hawaii), Mexico, Australia and New Zealand.

We are fortunate to have David Nowell to introduce the recent review of the Interna-tional Standard for Phytosanitary Measures No. 3 (ISPM No. 3) which provides guidelinesfor risk management relating to biological control agents. This review of the 1996 ‘Code ofConduct for the Import and Release of Biological control Agents’ has only recently beencompleted in April this year, and David Nowell as a member of the IPPC Secretariat wasdirectly involved with the review. He will explain the background and process of the review,and outline the aspects of the standard which have received most emphasis during the review.This standard will almost certainly continue to provide guidance for countries who are devel-oping their own legislative systems for biological control regulation, and as pointed out byFranz Bigler and co-authors in this session, the Code may be seen as a first attempt to harmo-nize regulation of biological control agents globally.

Harmonization of biological control regulation in Europe is the topic of the contribu-tion from Bigler and co-authors. The revised Code is perhaps now the opportunity for Eu-rope at least to harmonize its regulation of biological control, given their shared borders, thebiological control requirements that they have in common, and the similar biological controlsafety concerns of many European countries. So while achievement of harmonization is cer-tainly a political challenge, it is also an opportunity for some countries to review their, in


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some cases, inappropriate legislation of biological control. The OECD initiative to harmo-nize and simplify regulation of commercially produced biological control agents has been avery timely first step in this process. The OECD guidance document is intended to reducethe need for each country to repeat biosafety testing procedures that have already been com-pleted in other countries. Furthermore, it will open up opportunities for commercial produc-ers to expand the use of their products more easily, and facilitate opportunities for use ofbiological control options.

Continuing with the theme of harmonization across shared borders, Peter Mason fromCanada and his co-authors from the U.S.A. and Mexico address the question of whetherlegislation can facilitate biological control opportunities in North America. To some extentthere has been some harmonization in data requirement for entomophagous biological con-trol agent proposals in that the three countries have agreed to conform to NAPPO guidelines.As in Europe, this would achieve gains for biological control by more readily allowing infor-mation sharing. Furthermore the authors point out that a scientific approach to the approvalprocess is likely to ensure that only safe and effective biological control agents are introduced.However, currently the regulatory system with the U.S.A. is cumbersome with a mixture ofFederal and inconsistent State jurisdiction. Russel Messing provides an overview of the sys-tem for biological control regulation in Hawaii, the State where the most rigorous reviewprocedure has been adopted. While the system appears to be exhaustive in ensuring environ-mental safety of biological control, and allows for a degree of public consultation, it is steepedin bureaucracy that results in frustration and lengthy delays for biological control practitio-ners. The case is made for the best of the Hawaiian system to be adopted generally in theU.S.A., but improvements made in efficiency and transparency.

Like Hawaii, two island nations where shared borders are not an issue, and completecontrol over imported biological control agents can be achieved are Australia and New Zealand.Harrison and co-authors describe and compare the regulatory legislation in these countries.The HSNO Act in New Zealand has attracted considerable attention internationally as veryenvironmentally focussed legislation, and the implementation of it by ERMA NZ has beenobserved with interest. In Australia, biological control agents are regulated by two agenciesunder three separate Acts, and has been similarly heralded as a thorough and biosafety-con-scious approach. The authors provide a useful analysis of the two systems illustrating veryclearly some key differences in approach, and the implications of these, particularly in theareas of scope of the regulatory process, opportunity for public participation, and degree ofrisk-aversion of the regulatory agencies.

In this session we asked the authors to address challenges and opportunities presentedby biological control legislation, and several themes have emerged from both perspectives.We take the approach that each challenge in turn presents an opportunity. One of the majorchallenges for regulators that most authors have acknowledged is the need to manage theuncertainty inherent in risk assessment for biological control agents, specifically host-speci-ficity determination and prediction of post-release impacts based on quarantine laboratorytesting. The opportunity here is for researchers to continue to address this issue and to extractmaximum value from post-release validation studies. In Europe and North America, the po-litical and/or bureaucratic challenges are to develop regulatory frameworks that recognise

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shared borders and the advantages of a coordinated, harmonized approach across sovereignor regional state boundaries. The respective authors have emphasised the opportunities thatcan be realised from harmonization, and the benefits for biological control that can poten-tially accrue from such an approach. The authors commenting on the U.S.A. regulatory sys-tem have highlighted the bureaucratic complexity and the challenge to legislators to improvedefficiency, consistency and public participation in biological control regulation. The oppor-tunity will then be there for biological control practitioners to work within a time-bound andsimplified process where they can interact with the public. Finally in Australia and NewZealand, one of the challenges identified (which almost certainly applies generally) is to con-vince biological control practitioners that the regulatory process should be seen not as anobstacle, but an opportunity for constructive peer review, improvement of the public profileof science as well as the opportunity to conduct high quality research for good of people, theeconomy and the environment.

We hope that in bringing together this mix of authors from regulatory and science per-spectives, we can benefit from the exchange of ideas and an improved understanding of howa range of regulatory systems operate. The biggest challenge and opportunity of all is to capi-talise on the best aspects of each and the collective wisdom that has been presented, so thatglobally we can maximise the opportunity for safe, cost-effective biological control.


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HAWAII AS A ROLE MODEL FOR COMPREHENSIVE U.S.BIOCONTROL LEGISLATION: THE BEST AND THE WORST OF IT

Russell H. MESSING

University of Hawaii7370 Kuamoo Rd.

Kapaa, Hawaii, U.S.A. 96746

[email protected]

ABSTRACT

The United States currently has no comprehensive, integrated legislative or regulatory frame-work to manage the permitting of imported biological control agents. There are unresolvedquestions of whether the USDA - Animal and Plant Health Inspection Service (APHIS) hasjurisdiction over parasitoids that are not plant pests; there are differences in protocol betweenweed and arthropod biocontrol agents; there are unresolved issues of State vs. Federal au-thority; and there are overlapping and ever-changing requirements from a wide assortment ofFederal and State agencies and a diverse array of laws that were designed for other purposes.In contrast, the State of Hawaii has specific, detailed, and exhaustive rules for obtaining im-port and release permits for natural enemies. In some respects the Hawaii system could serveas a useful model for national protocols - with coordinated scientific evaluation at severallevels of specialization, and input from a wide range of concerned parties. However, someaspects of this system lead to bureaucratic entanglements and unconscionable delays thathinder the practice of biological control in the islands. If we could capture the best parts ofthe Hawaii system and mitigate the legalistic and bureaucratic redundancy, then a thorough,streamlined, efficient, transparent, accountable, and enabling regulatory framework could beput in place that would safeguard non-target species while facilitating biological control andenvironmentally sound pest management at the national level.

INTRODUCTION

Classical biological control is a powerful tool for pest management that has been used suc-cessfully for over a hundred years in the United States to combat invasive arthropod andweed species. For the greater part of the past century, regulations governing the importationof exotic beneficial species were either non-existent or were cobbled together from a diversearray of tangential legislation that was designed for other purposes, often only marginallyrelated to the most important issues of biocontrol. Within the past decade, however, a con-sensus has emerged, both among conservation biologists and applied (primarily agricultural)entomologists, that some form of regulation specific to the importation of biological controlagents should be established. However, the devil is in the details, and the few attempts thatthe United States Department of Agriculture, Animal and Plant Health Inspection Service

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(USDA-APHIS) has made to establish regulations have been (and continue to be) chaotic,poorly understood, and difficult to implement. The increased scrutiny of both hand-carriedand shipped packages following the terrorist attacks in the U.S. in 2001, and the bureaucraticre-organization of APHIS (with segregation of a separate Department of Homeland Secu-rity) has further complicated and confused efforts to put a manageable regulatory frameworkin place.

This short paper will first give an overview of the regulatory process in Hawaii, themost stringent system for oversight of biological control in the United States. I’ll then brieflycompare the State system to the existing U.S. Federal system, and point out the strengths andthe weaknesses in Hawaii’s rules that can provide valuable guideposts to those charged withestablishing a much-needed national policy.

THE REGULATORY PROCESS IN HAWAII

At its core, the system in Hawaii for regulating newly imported biological control agents is alogical and thorough process with some admirable features that were no doubt designed withthe best intentions in mind. The applicant is required to file a dossier with the State Dept. ofAgriculture Plant Quarantine Branch (PQ) containing information about the taxonomy, bio-nomics, ecology, and host range of the proposed species introduction, as well as a justifica-tion for its importation, person responsible for the insects, description of safeguard facilities,method of disposal, and relevant supporting literature.

PQ then submits the application to two different committees for review. The firstadvisory committee is composed of disciplinary specialists (for example, a proposed arthro-pod introduction would be reviewed by the Entomology Committee). This committee iscomprised of individuals representing a wide spectrum of opinion and expertise within thestate, from agricultural pest management to insect conservation, from University professorsto State agricultural entomologists to Museum specialists.

The Entomology Committee’s comments are then forwarded for secondary review toanother advisory committee with a broader range of expertise. For example, a botanist, a fishand wildlife specialist, a zookeeper, and a public health specialist sit on this Plants and Ani-mals Advisory Committee. This second level of review considers the comments of the ento-mological experts, as well as the broader ecological and economic context of all new speciesintroductions. Their decision, which is non-binding but highly influential, is passed on to theState Board of Agriculture, which reaches a final decision, that still must, however, by signedby the Governor. In addition, a concurrent Federal permit must be in place before any organ-ism may be removed from quarantine.

The State process has two distinct components: the first requires placing a proposedspecies introduction on a specific list; the second requires establishing all of the conditionsunder which an organism on that list can actually be imported and released. As part of thelisting process, public hearings are held throughout the state, during which concerned citi-zens can provide their input regarding the proposed introduction. These public commentsare part of the final dossier used by the Board of Agriculture to make its decision.


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In theory, the overall system provides for a fair and thorough review with input from allconcerned parties, but in practice its implementation becomes bogged down in a bureaucracythat even the administrators of the process have difficulty in understanding and controlling(for details, see Messing and Purcell 2001). The listing process is subject to repeated and long-delayed reviews by the state Attorney General’s office to ensure compliance with legal tech-nicalities. The fact that two different steps are required (first the listing, and then the estab-lishment of conditions for release) means that the same dossier is sent to the various commit-tees and attorneys and Board twice (in succession), rather than considering both steps simul-taneously. There is no established time schedule for any of the steps, and no accountabilityfor any person or committee that fails to complete a step in a reasonable time frame. Commit-tees and the Board sometimes do not meet for lack of a quorum. Because of the cost of hold-ing public hearings on different islands, applications are held until a sufficient batch accumu-lates to justify the expense of organizing and holding the meetings. If there is a problem witha single application in a batch, the entire listing process is delayed – including those applica-tions that are problem-free. There is a lack of communication between State and Federal of-fices, each of which requires the consent of the other. There is no process for online tracking,nor of reporting the status of a submission to the applicant. It is not unusual for an applica-tion to take years, rather than months, to make it through the listing process, even in caseswhere no additional biological data are requested. The process has become so onerous that itis significantly hindering the practice of biological control in the state (Messing 2000).

THE UNITED STATES FEDERAL (APHIS) REGULATORY PROCESS

The United States Department of Agriculture Animal and Plant Health Inspection Servicehas the statutory authority to regulate plant pests entering the U.S. While the agency tradi-tionally has also issued permits for the introduction of entomophagous biological controlagents, there are legal questions of whether, for example, a host-specific insect parasitoid canbe considered a plant pest. Despite the fact that the Plant Protection Act of 2000 [PUBLICLAW 106–224; section 412.a] specifies biological control organisms as subject to regulation,APHIS has been reluctant to take on this responsibility overtly, yet at the same time unwill-ing to relinquish all control given the lack of any other regulatory authority.

Some applicants for biocontrol permits are obliged to write and submit an Environmen-tal Assessment (EA), a legal document that describes the expected impact of a non-indig-enous organism on the environment. This document addresses both positive and negativeenvironmental impacts; those deemed to have a higher risk are then required to prepare amore detailed environmental impact statement (EIS); those of lower risk are issued a findingof no significant impact (FONSI). The EA is a requirement of the National EnvironmentalPolicy Act (NEPA), but it is only required for employees of Federal agencies (or for projectsconducted with Federal funds), not for State projects. NEPA also requires consultation withthe U.S. Fish and Wildlife Service and other Federal agencies, but again, only for those projectswith Federal backing.

APHIS has a fairly well established system for regulating the introduction of weedbiocontrol agents (overseen by a Technical Advisory Group, TAG) – since herbivorous



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arthropods obviously have the potential to become plant pests. Imported plant pathogens, onthe other hand, are considered similar to pesticides and are regulated by the U.S. Environ-mental Protection Agency (EPA). For entomophagous arthropods, however, the situationbecomes murky: APHIS requires a permit to import species into U.S. quarantine facilities,but then generally leaves it to State Departments of agriculture to make final determinationson field release of organisms from quarantine. For several years the agency has issued “lettersof no-jurisdiction” for release – in essence turning responsibility over to the states.

In practice, however, and particularly recently, APHIS has instituted new rules, with-out significant public comment, regulating both the importation of organisms into quaran-tine and their removal from quarantine. For example, no hand-carrying of biological controlagents by foreign explorers is allowed, only licensed, bonded carriers are to carry packagesacross national borders; shipments are to be routed through APHIS facilities in Beltsville,Maryland prior to their final destination in State quarantine facilities. Removal from quaran-tine requires consultation and thorough review of dossiers by Canada and Mexico under theauspices of NAPPO, the North American Plant Protection Organization. NAPPO has itsown template of data requirements, including detailed plans for post-release monitoring andevaluation.

GUIDELINES FOR A NEW SYSTEM

It is admittedly difficult (though no less necessary) to institute a comprehensive Federal sys-tem for regulating imported biological control agents. Efforts are complicated by legitimateconcerns for agro-terrorism; by the complex, diverse, and idiosyncratic nature of arthropodbiologies; by geographic anomalies inherent in having some states contiguous with interna-tional borders while other states are geographically isolated. Furthermore, inter-agency bu-reaucratic squabbling, inadequate funding, and the short-sighted dissolution by APHIS ofthe National Biological Control Institute, leave federal, state, private, and university biocontrolpractitioners with no adequate channel for communicating needs and concerns to the agency.

Other countries, particularly Australia (McFayden 1997) and New Zealand (Fowler etal. 2000), have overcome these obstacles and established effective regulatory policies for bio-logical control. Hawaii, as we have seen, has regulations that are effective in safeguarding theenvironment (Funasaki et al., 1988, Henneman and Memmot 2001), though not, to under-state the case, particularly efficient. Rather than re-inventing the wheel, APHIS should incor-porate the best of Hawaii’s system while avoiding its bureaucratic pitfalls.

The strengths of the Hawaii system are that there are several layers of review with dif-ferent perspectives (narrow disciplinary specialists and broader ecological and economic per-spectives); that within each committee there is a deliberate choice of individuals with a widerange of opinion and expertise; and that there is a formal public notification and input pro-cess, whereby the concerns of all interested citizens are taken into account.

The fact that Departments of Agriculture oversee the biocontrol permitting process (bothin Hawaii and at the Federal level) is an historical accident; targets for biological control andenvironmental impacts of greatest concern have traditionally been in agricultural settings. Itmay be argued, however, that this a case of the fox guarding the henhouse, since the Depart-


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ments’ mandate is by nature agro-centric. Now that biological control is becoming morecommonly accepted as a tool for pest management in non-agricultural settings (Hoddle 2004),and as environmental impacts are increasingly viewed in non-economic terms, it is more logi-cal to have an independent environmental agency supervise the process, as is done in Austra-lia and New Zealand.

The weaknesses in Hawaii’s permitting system, alluded to earlier, are partially theresult of specific state laws specifying the need for continuous revising and updating of com-plete lists of imported non-indigenous species. The listing process is frought with legal tech-nicalities that necessitate repeated review by attorneys who have little knowledge of biology;with no equivalent Federal listing requirement, much of this bureaucracy could be reduced.The use of strictly formatted templates for data entry and evaluation could also help eliminaterecurring legal reviews.

APHIS’ own TAG system, with a Technical Advisory Group evaluating proposedweed biocontrol agents, could be readily adopted for arthropod biocontrol agents, and madeeven stronger by adopting Hawaii’s system of a two-tiered review process (i.e., specialists and“generalists”). To the extent that NAPPO consultation requires additional review by neigh-bor countries, the key to a fair and timely response to the applicant is to have as many of thesereviews as possible conducted simultaneously.

Online forms and electronic input of all dossier information, comments, and concernscan make the entire system more efficient, responsive, and transparent. APHIS has recentlystarted to gather input on the best way to take this step, but at present the only informationavailable on their web site is a downloadable form (PPQ 526), a list of NAPPO dossierguidelines, and some answers to Frequently Asked Questions (see figure showing home pagebelow).



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Timeliness is of utmost concern when biocontrol practitioners are rearing living colo-nies of arthropod predators or parasitoids at great expense and possible irreplacable loss ofgenetic diversity. Timelines in the permit process should be strictly specified and firmly ad-hered to, so that a lack of response during a specified comment period does not stall an appli-cation, but rather is interpreted as “no objection”. Input from the general public can be ob-tained by electronic notification of a broad suite of interested parties, and by appropriatepublic advertising and a transparent web site.

Chemical pesticides continue to become less available to land managers due to insectdevelopment of genetic resistance and loss of product registration due to public health con-cerns. However, invasive species continue to plague our farms, cities, and natural ecosystemsat an increasing rate; thus biological control is becoming more important than ever as a valu-able tool for safe and cost effective pest management. For the benefit of the nation’s agricul-ture as well as its natural environments, APHIS (or another Federal agency) should adoptregulations that are thorough, streamlined, efficient, transparent, accountable, and that facili-tate rather than hinder the practice of biological pest control.

REFERENCES

Fowler, S. V., Syrett, P., and Jarvis, P. J. 2000. Will expected and unexpected non-targeteffects, and the new Hazardous Substances and new Organisms Act, cause biologicalcontrol of broom to fail in New Zealand? In: N. R. Spencer, Ed. “Proceedings of the XInternational Symposium on the Biological Control of Weeds”. 4-14 July 1999, MontanaState University, Bozeman, Montana, U.S.A.

Funasaki, G. Y., Lai, P. Y., Nakahara, L. M., Beardsley, J. W., and Ota, A. K. 1988. Areview of biological control introductions in Hawaii: 1890 to 1985. Proceedings of theHawaiian Entomological Society 28,105-160.

Henneman, M. L. and Memmott, J. 2001. Infiltration of a remote, endemic Hawaiian com-munity by introduced biocontrol agents. Science 293, 1314–1316.

Hoddle, M. S. 2004. Restoring balance: Using exotic species to control invasive exoticspecies. Conservation Biology 18, 38-49.

McFadyen, R. 1997. Protocols and quarantine procedures for importation and release ofbiological control agents, pp. 63-69. In “Biological Control of Weeds: Theory and Prac-tical Application” (M. Julien, and G. White, Eds.) ACIAR Monograph Series, Canberra,Australia.

Messing, R. H. and M. F. Purcell. 2001. Regulatory constraints to the practice of biologicalcontrol in Hawaii. In “Balancing Nature: Assessing the Impact of Importing Non-Native Biological Control Agents”. (J. Lockwood, F. Howarth, and M. Purcell, Eds).Thomas Say Publications in Entomology, Entomological Society of America, LanhamMaryland.

Messing, R. H. 2000. The impact of non-target concerns on the practice of biological con-trol. In “Non-target Effects of Biological Control”. (P. Follett and J. Duan, Eds). KluwerAcademic Publishers, Norwell, MA.


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HARMONIZATION OF THE REGULATION OF INVERTEBRATEBIOLOGICAL CONTROL AGENTS IN EUROPE

Franz BIGLER1, Antoon LOOMANS2, and Joop VAN LENTEREN3

1Swiss Federal Research Station for Agroecology and Agriculture8046 Zürich, [email protected]

2Plant Protection ServiceP.O. Box 9012

6700 Wageningen, The [email protected]

3Wageningen Agricultural Research Center, Laboratory of EntomologyP.O. Box 8031

6700 Wageningen, The [email protected]

ABSTRACT

The regulation of import and release of invertebrate biological control agents is not harmo-nized yet in Europe. Each country has its own regulatory system in place that is legally basedon either the nature protection and/or the Plant Protection Act. The publication of the FAOCode of Conduct in 1996 for import and release of exotic biological control agents was theturning-point for the activities related to the import and release of biological control agents inEurope. An EPPO expert panel developed from 1998 to 2002 two guidelines on the safe useof biological control and established a list of biological control agents widely used in theEPPO region. An EU funded project with the goal to develop scientific methods for evaluat-ing environmental risks of biological control introductions into Europe (ERBIC) was con-ducted from 1998 to 2002. In 1999, the OECD initiated a working group with the aim todevelop a guidance document on appropriate regulation of invertebrate biological controlagents. Biological control industry was very concerned about these developments and pro-posed to the International Organization for Biological Control (IOBC/WPRS) to co-ordi-nate harmonization among European countries. A commission of the IOBC/WPRS was putin place in 2003 with the aim to facilitate and harmonize regulation in Europe. In 2004, theEU released a call for project proposals with the aim to develop a balanced system for harmo-nized registration of biological control agents.

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INTRODUCTION

In the past, Europe has generally been a source rather than a recipient of invertebrate biologi-cal control agents in comparison to other countries with extensive experience in classical bio-logical control, such as Australia, Canada, New Zealand, South Africa and the U.S.A. Thesecountries had legislation and procedures in place relatively early to regulate imports and toanalyze risks of exotic biological control agents (Sheppard et al. 2003). Most classical biologi-cal control programs in Europe have focused mainly on controlling exotic pests in the Medi-terranean region. Today, there is a growing interest in classical biological control of invasiveweeds throughout Europe, especially in conservation areas (Waage 1997). Increasing interna-tional trade in agricultural products and growing accidental introductions of organisms re-lated to tourism and global trade are nowadays important sources of new imports of exoticpest species into Europe, as demonstrated by Bin and Bruni (1997) for Italy. Many of theseintroduced organisms are candidates for classical biological control if they establish in con-servation reserves where they may threaten native species and communities. Most if not allEuropean countries are signatories of the Convention on Biological Diversity and, thus, havethe obligation to prevent the introduction and, as far as possible, to control those alien speciesthat threaten indigenous ecosystems and habitats. Because chemical and mechanical controlof such organisms may have negative effects on ecosystems greater than those of the intro-duced alien species itself, classical biological control may offer adequate solutions.

Protected crops grown in glasshouses have developed rapidly in many European andMediterranean countries, and the protected environment has favored the temporary or per-manent establishment of imported pests. On the other hand, customers in most Europeancountries are increasingly concerned about pesticide residues in food, and food quality regu-lations are becoming more stringent in Europe where most of the glasshouse crops are mar-keted. This situation offers new avenues for non-chemical pest control. Biological control byaugmentation or inundation has developed during the last 35 years and is now a major com-ponent of pest control in protected crops. About 90 species of invertebrate biological controlagents are presently on the EPPO list of widely used and commercialized biological controlagents in the EPPO region (EPPO 2002), and many more are under investigation for futurerelease. Some agents on this list may have disappeared from the market, but new ones havecome up in the meantime. Europe leads the world in this activity, and national regulatoryagencies have therefore an obligation to rule and facilitate international trade in an efficientand appropriate way.

Regulations for introductions of invertebrate biological control agents differ betweenEuropean countries and some have yet to establish these (Bigler 1997; 2001). Obligations ininternational laws and agreements, and an increasing interest in the import and release ofexotic biological control agents calls for harmonized and better regulation between Europeancountries. In many cases introductions of invertebrate biological agents are administered un-der regulations which were established for other purposes, such as plant quarantine, wildlifeconservation and genetically modified plants. The application of appropriate regulatory pro-cedures is important in order to maintain public confidence in biological control and to facili-tate introductions and the commercial use of exotic biological control organisms.


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ACTIVITIES AND DOCUMENTS TO FACILITATE HARMONIZEDREGULATION IN EUROPE SINCE 1995

THE FAO CODE OF CONDUCT

The FAO Code of Conduct for the Import and release of Exotic Biological Control Agentswas adopted in 1995 by the FAO Conference and published in 1996 as the InternationalStandard for Phytosanitary Measures No. 3 (IPPC 1996). One objective of the Code was toprovide a standard for those countries that are lacking adequate legislation and procedures toregulate import and to analyze risks related to biological control agents. The document listsin a generic way the responsibilities of the authorities and importers and exporters of biologi-cal control agents. Furthermore, it recommends that governments already fulfilling the objec-tives of the Code may adapt their existing regulatory systems in the light of this guidance.This objective of the Code may be interpreted as being the first attempt to harmonize regula-tion of biological control agents worldwide. The revised version of this Code of Conduct hasextended its range from classical biological control to inundative biological control, nativenatural enemies, microorganisms and other beneficial organisms, and also includes evaluationof environmental impacts (IPPC 2005). The publication of the FAO Code can be consideredas the turning-point for a number of activities related to import and release of invertebratebiological control agents in Europe.

EPPO GUIDELINES AND ‘POSITIVE LIST’

Shortly after the Code’s publication, the European and Mediterranean Plant Protection Or-ganization (EPPO) together with CABI Bioscience organized a workshop on safety and effi-cacy of biological control in Europe (EPPO 1997). In its recommendations, the scientificcommittee of the workshop noted that “…practices for the import of macrobiological agentsat present vary greatly between European countries. These practices should be harmonized,with appropriate conditions recommended for importation for different purposes, e.g. re-search, classical, commercial biocontrol.” The workshop suggested that an EPPO Panel shouldbe established, and promote the adoption of harmonized practice for the import of inverte-brate biological control agents. The workshop broadly endorsed the FAO Code and recom-mended that guidelines be drawn up to meet European needs with respect to the differentlegislations and regulations. It was stressed that the guidance on harmonized regulation shouldnot slow the process of import of biological control agents, be it for first introduction forresearch or for release later on. The workshop concluded that a certification system should beput in place for Europe instead of a registration procedure, to ensure a ‘light’ regulatorysystem with efficient and rapid mechanisms.

The registration system for microbial biological control agents in place in the EU underDirective 91/414/EEC was given as a negative example of regulating biological control agents.This Directive accommodates the registration of microbiological control agents since 1992,and experience over the years has shown that the Directive and its implementation is so strin-gent that it is basically impossible to register a new microorganism in the EU countries. Theworkshop decided to establish an expert panel with the aim of drawing up more specificguidelines and to prepare a ‘positive list’ of invertebrate biological control agents that are



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widely used in the EPPO region without any reports on adverse effects. The EPPO panel meta number of times between 1998 and 2002 and the results were published in two guidancedocuments and in a ‘positive list’ of organisms for safe use in EPPO countries. The firstguideline recommends a system for the first import of exotic biological control agents forresearch under contained conditions (EPPO 1999). The second document gives guidelinesfor the import and release of exotic biological control agents, including information on howto prepare a dossier by the applicant for the national authority and on how the authorityshould examine the dossier (EPPO 2001). The two guidelines stress the importance of a two-step system for import and release, i.e., EU countries should first establish a regulatory pro-cess for import of exotic organisms for research under containment. The results of these in-vestigations will provide the necessary data to make decisions on whether the organism canlater be imported for release. The approval for release will be granted if further studies showthat the organism is safe for the environment and humans. To facilitate and speed-up the useof invertebrate biological control agents in the EPPO region, a list of commercially availableorganisms was first published (EPPO 2002) with the idea to regularly adapt the list depend-ing on new information.

THE ERBIC RESEARCH PROJECT

In parallel with the EPPO panel activities, the EU-funded research project ERBIC (Evaluat-ing Environmental Risks of Biological Control Introductions into Europe) was executed from1998 to 2002. Among the objectives, major aims were: 1) to ensure that the introduction anduse of biological control agents is done in a way which does not put at risk non-target organ-isms, 2) to develop rapid and reliable methods to assess the potential risk of import and re-lease of biological control agents in Europe, and 3) to design specific European guidelines toensure that biological control agents are environmentally safe. One of the main outcomes ofthe project was the proposal for the environmental risk assessment of exotic natural enemiesin inundative biological control (van Lenteren et al. 2003). This paper presents for the firsttime detailed criteria for risk assessment and a ranking system that is based on the quantitativeevaluation of more than 30 invertebrate biological control agents used in inundative controlin Europe.

THE OECD GUIDANCE DOCUMENT

An initiative starting from a meeting held in Canada in 1999 resulted in an activity of OECD( Organization for Economic Co-operation and Development) countries with the aim to de-velop a harmonized approach for regulation of invertebrate biological control agents. It wasagreed that a harmonized regulatory system in the OECD member countries would be ben-eficial for biological control and that a ‘light’ form of regulation would be appropriate. Thedevelopment of harmonized guidance for regulation requirements would enable companiesto submit the same applications to many countries, and would allow regulatory agencies tobenefit from each other’s reviews. The document (OECD 2004) proposes guidance to mem-ber countries on information requirements for a) the characterization and identification ofthe organism, b) the assessment of safety and effects on human health, c) the assessment ofenvironmental risks and d) the assessment of efficacy of the organism. It is however, thedecision of member countries whether and how these organisms are regulated, and countries


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may require additional information to meet national or international requirements. With na-tive or established organisms and with those long in use in a country, substantially reducedinformation requirements may be appropriate.

A BOOK ON METHODS OF RISK ASSESSMENT FOR BIOCONTROL AGENTS

Attempts to implement the EPPO, ERBIC and OECD documents into national regulatorysystems in a number of European countries have shown that the required information anddata are in many cases not available and have to be produced prior to submission of a dossierto the national authority. It became also evident that the framework of environmental riskassessment that should be used for the preparation of the dossiers by the applicants and theevaluation by national authorities was not yet established in Europe. The lack of methodol-ogy for risk assessment of invertebrate biological control agents was recognized by the Euro-pean biological control community, and consequently, 25 experts from across the world gath-ered for a workshop in Switzerland in 2004 to put together a synthesis of current knowledge,and to provide recommendations for further regulatory guidance in this area. The emphasiswas on providing science-based guidance for those assessing and evaluating environmentalrisks, and on providing up-to-date information on existing methods and their application forevaluating non-target effects. The starting point was to address all the information require-ments for environmental risk assessment laid out in the recent OECD publication (OECD2004). A further aim was to compile all this information for a book, which is to be publishedby CABI Publishing (Bigler et al. 2006).

THE IOBC/WPRS COMMISSION FOR HARMONIZATION OF REGULATION

The European biological control industry was very concerned when the OECD guidancedocument was published as the information requirements were considered to be too strin-gent, and manufacturers feared that each national authority in Europe would establish theirown regulatory system. As a consequence, the International Biocontrol Manufacturer Asso-ciation (IBMA) proposed to the International Organization for Biological Control (IOBC/WPRS) to co-ordinate harmonization among the European regulatory authorities. A Com-mission of the IOBC/WPRS was put in place in 2003 with the objectives to 1) collect infor-mation on regulation in European countries and compile an overview, 2) organize a work-shop with countries that have participated in the data compilation together with the biocontrolindustry and regulators, 3) produce a document that gives detailed guidance on regulationprocedures for exotic and indigenous biocontrol agents, 4) up-date EPPO’s list of safe organ-isms, 5) propose a consultation procedure that will allow exchange and use of informationand data on biological control agents between European countries and 6) propose a Europeanexpert group for invertebrate biological control agents. The first meeting of the Commissionwas held in 2004 with the participation of scientists, regulators and industry representativesfrom 15 European countries and resulted in fulfillment of objectives 1 to 3. The document oninformation requirements for import and release of invertebrate biological control agents inEuropean countries (Bigler et al. 2005) gives more specific advice to applicants and nationalauthorities on information required for risk assessment compared to the EPPO and OECDdocuments cited above, and it reduces data requirements for facilitating regulation, but stillrespecting concerns of human and environmental safety. Proposals for objectives 4 to 6 willbe elaborated in a future workshop.



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THE EU CALL FOR A BALANCED SYSTEM OF REGULATION

In October 2004, the Directorate-General for Research of the European Commission re-leased a call for project applications with the aim to develop a balanced system for regulationof biological control agents (micro- and macro-organisms), semiochemicals and botanicals.The call specifies that, despite considerable research efforts on biological control, the numberof microbiological products on the market in Europe is currently still low, compared to othercountries, e.g., the U.S.A. and Canada. The aim of the task is to review current legislation,guidelines and guidance documents and to compare this with similar legislation in other coun-tries where the introduction of new biopesticides has proven to be more successful. Newappropriate and balanced regulatory systems should be designed, provided that no compro-mises are made to the level of safety. This is the first time that the EU has become involved inregulatory affairs of invertebrate biological control agents with the intent to harmonize na-tional systems of EU countries and hence, it can be expected that in few years from now, theEU members and other European countries may regulate invertebrate biological control agentsunder uniform principles.

REGULATION REQUIREMENTS IN EUROPEAN COUNTRIES IN 2004

For the preparation of the workshop organized by the IOBC/WPRS Commission on theharmonization of regulation of invertebrate biological control organisms held in 2004, and infulfillment of objective 1 of the Commission (see above), we have sent out questionnaires toregulatory authorities and biological control scientists in 19 European countries. Replies werereturned by all countries, although the quality of information provided differed greatly be-tween countries. Nevertheless, the questionnaires yielded interesting information and datawhich are presently being compiled and prepared for publication. All countries addressed bythe questionnaires have national legislations in place. However, large differences exist in thedegree of implementation of regulatory measures of invertebrate biological control agents inthese countries as demonstrated in Figure 1. The present status of regulation has been as-signed to three categories: a) regulation is implemented to some degree in eight countries(Austria, Czech Republic, Denmark, Hungary, Norway, Sweden, Switzerland, U.K.), b) fivecountries are working on the design and implementation of a regulation system (Finland,Germany, Netherlands, Slovenia, Spain) and c) six countries have no regulation implementedyet and will not have a regulatory system in place in the foreseeable future (Belgium, France,Greece, Italy, Poland, Portugal).

The results of the survey further demonstrated that the requirements differ largely be-tween European countries. Examples of differences are:

• the assignment of a competent national authority (plant health, pesticide registration orenvironmental authority),

• the information requirements for evaluation of a dossier and subsequent level of risk as-sessment,

• whether native species have to be regulated as well; when regulation is required, nativespecies usually follow a “short track” risk assessment, whereas exotic species are assessedmore thoroughly,


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• the system of regulation: by authorization, by permit, etc.

• listing of biological control species based on commercial availability or on risk based evalu-ation.

The survey also showed that there is a need for harmonization on a European level.Initiatives with respect to information requirements for import and release have already beentaken (Bigler et al. 2005).

Figure 1. Present status of regulation of invertebrate biological control agents in 19 Europeancountries. Countries where regulation has been implemented are indicated withgreen dots, countries where regulation is in preparation with yellow dots and thosewithout regulation in place with orange dots.

CONCLUSIONS

Attempts to harmonize regulation of invertebrate biological control agents in Europe havebeen undertaken since the publication of the FAO Code of Conduct in 1996, and regulatoryguidelines developed by international organizations, such as the EPPO and OECD duringthe last ten years, have been adopted and implemented by national authorities in a few Euro-pean countries. Given that legislation for the regulation of invertebrate biological controlagents differs among European countries and that laws are not yet in place in some countries,responsibilities are often not yet clearly assigned to ministries or government agencies onnational levels. Different regulations among European countries may cause serious problemsto the biocontrol industry as dossiers must respect national requirements and criteria in those



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countries where regulation is in place. This makes applications more time consuming andcostly, and can be a factor for a company to decide not to develop the organism to a productif the market potential is estimated low in comparison to the development costs. Past experi-ence has shown that overregulation, i.e., rigid legislation with stringent data requirementsmay keep such products off the market for a long time or even prevent industry from submit-ting applications in some countries. This situation has been experienced in the EU since 1992with the registration of microbial biocontrol agents that are regulated under the Directive 91/414/EEC which largely follows requirements developed for synthetic pesticides. Costly riskassessment studies and long term evaluation of dossiers has kept most products off the mar-ket and resulted for the few registered micro-organisms in an average evaluation period perproduct of over 70 months (Blum et al. 2003). Uncoordinated regulation of biological controlorganisms bear the risk that approval for release in one country may have impacts for othersif the organism crosses borders and establishes in other countries. A recent example is theestablishment of Harmonia axyridis, the Multicolored Asian Lady beetle, in European coun-tries like Switzerland, where the application for release of this coccinellid was rejected in thenineties based on documented non-target effects. Releases in other European countries hasresulted in the establishment of the lady beetle and in crossing borders and invading othercountries. This and other examples demonstrate that Europe urgently needs a harmonizedregulation of biological control agents which will prevent import and release of unsafe organ-isms, but which will not put an unnecessary burden on biological control.

REFERENCES

Bigler, F. 1997. Use and registration of macro-organisms for biological crop protection.EPPO Bulletin 27, 95-102.

Bigler, F. 2001. Safe use of invertebrate macro-organisms for biological control in theEPPO region. EPPO Bulletin 31, 405-410.

Bigler, F., Babendreier, D., and Kuhlmann, U. 2006. Environmental risks of invertebratebiological control agents: Methods and risk assessment. CABI Publishing, WallingfordU.K. (in press).

Bigler, F., Bale, J., Cock M., Dreyer, H., Greatrex, R., Kuhlmann, U., Loomans, A., andvan Lenteren, J. 2005. Guideline on information requirements for import and release ofinvertebrate biological control agents in European countries. Biocontrol News and Infor-mation (in press).

Bin, F., and Bruni, R. 1997. Evaluating one century of classical biocontrol in Italy. EPPOBulletin 27, 53-59.

Blum, B., Ehlers, R, Haukeland-Salinas, S., Hokkanen, H., Jung, K., Kuhlmann, U.,Menzler-Hokkanen, I., Ravensberg, W., Strasser, H., Warrior, P., and Wilson, M., 2003.Biological control agents: Safety and regulatory policy. BioControl 48, 477-484.

EPPO. 1997. EPPO/CABI workshop on safety and efficacy of biological control agents inEurope. EPPO Bulletin 27, 1-3.


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EPPO. 1999. First import of exotic biological control agents for research under containedconditions. EPPO Bulletin 29, 271-272.

EPPO. 2001. Import and release of exotic biological control agents. EPPO Bulletin 31, 33-35.

EPPO. 2002. List of biological control agents widely used in the EPPO region. EPPOBulletin 32, 447-461.

IPPC. 1996. Code of conduct for the import and release of exotic biological control agents.FAO, Rome. Publication No. 3, pp.21.

IPPC. 2005. Guidelines for the export, shipment, import and release of biological controlagents and other beneficial organisms. FAO, Rome. (in press).

OECD. 2004. Guidance for information requirements for regulations of invertebrates asbiological control agents. OECD Environment, Health and Safety Publications. Series onPesticides 21, pp. 22.

Sheppard, A. W., Hill, R., DeClerck-Floate, R. A., McClay, A., Olckers, T., Quimby Jr., P.C., and Zimmermann, H. G. 2003. A global review of risk-benefit-cost analysis for theintroduction of classical biological control agents against weeds: a crisis in the making?Biocontrol News and Information 24, 91N-108N.

Van Lenteren, J. C., Babendreier, D., Bigler, F., Burgio, G., Hokkanen, H. M. T., Kuske, S.,Loomans, A. J. M., Menzler-Hokkanen, I., van Rijn, P. C. J., Thomas, M. B., Tommasini,M. G., and Zeng, Q. Q. 2003. Environmental risk assessment of exotic natural enemiesused in inundative biological control. BioControl 48, 3-38.

Waage, J. 1997. Global developments in biological control and the implications for Europe.EPPO Bulletin 27, 5-13.

___________ How Can Legislation Facilitate the Use of Biological Control of Arthropods in North America?


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HOW CAN LEGISLATION FACILITATE THE USE OFBIOLOGICAL CONTROL OF ARTHROPODS

IN NORTH AMERICA?

Peter G. MASON1, Robert G. FLANDERS2,and Hugo A. ARRENDONDO-BERNAL3

1Agriculture and Agri-Food Canada, Research Centre960 Carling Avenue

Ottawa, Ontario K1A 0C6, [email protected]

2USDA-APHIS-PPQ4700 River Road, Unit 133

Riverdale, Maryland 20737-1236, [email protected]

3Centro Nacional de Referencia de Control BiológicoKm 1.5 Carretera Tecomán-Estación FFCC

28120 Tecomán, Colima, [email protected].

ABSTRACT

The use of biological control agents is an integral component of biologically-based pest man-agement strategies. Although there have been many success stories and biological controlbecame synonymous with environmentally friendly pest management, during the last 20 yearsan increased awareness of biodiversity interactions resulted in concerns being raised aboutpotential negative effects. The outcome has been pressure to improve regulatory oversight ofbiological control and make the process transparent. In North America, oversight of biologi-cal control agents has fallen primarily under federal law and provincial/state laws have occa-sionally influenced release of biological control agents. Federal laws used are associated withPlant Protection Acts because these regulate plant pests and biological control agents havebeen viewed as indirect plants pests. In Canada and Mexico this has worked well for regulat-ing entomophagous biological control agents whereas, in the United States there were legalconcerns that have now been addressed by including a definition of a “Biological ControlOrganism” in the U.S. Plant Protection Act. Plant protection laws are appropriate for regu-lating biological control agents because they are designed to address movement of living or-ganisms associated with plants. Canada, Mexico and the United States are intricately linkedboth geographically and economically, and efforts have been made to harmonize the datarequirements for submissions. The North American Plant Protection Organization (NAPPO)document, “Guidelines for Petition for Release of Exotic Entomophagous Agents for the


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Biological Control of Pests” was implemented as a North American standard. The guidelinesact as a framework within which there is flexibility for reporting information based on con-tinually improving scientific methods. Judgement of a petition is carried out through aninternational scientific peer-review process that includes experts in the areas under each head-ing. Comments are collated and a recommendation is made to the responsible agency in thecountry where release is intended. To date the process has been effective and this approachcontinues to provide opportunities for improving oversight based on science and ensuringthat only effective agents are used. The future challenge is implementing a process that in-cludes a wider stakeholder community while maintaining objective and scientifically soundassessment of entomophagous biological control agents.

INTRODUCTION

Biological control is a cornerstone of pest management in many parts of the world. Use ofentomophagous biological control agents has resulted in important successes in reducing dam-age from pest species in a variety of manipulated systems and biological control has greatvalue in sustaining environmental health, particularly through reductions in pesticide use.These attributes indicate that use of entomophagous biological control agents will continueand even grow. However, debate is increasing on the need for greater regulatory oversight ofbiological control agents, including entomophagous species.

Factors that contribute to the need for greater regulation of biological control agentsinclude trade globalization and awareness of the importance of biodiversity. Expanded globaltrade has resulted in an astounding increase in the numbers of non-native species establishingin new habitats. Estimates suggest that invasive alien species are responsible for annual lossesof US$55-248 billion to worldwide agriculture (Bright 1999). More difficult to assess are en-vironmental costs due to habitat loss or species extirpation or extinction caused by invasivealien species (Parker and Gill 2002). Biological control is an important strategy for combatinginvasive alien species and it has been viewed as being ‘environmentally friendly’ for morethan 100 years. However, during the last decade as science and society have become increas-ingly aware of the importance of biodiversity to human well-being, a less positive view ofbiological control, particularly in island environments, has emerged especially with the intro-duction of generalist predators and non-specific herbivores (Howarth 1991; Simberloff 1992).This perspective is based on non-target/unintended impacts and has stimulated much debate(e.g., Follett and Duan, 2000; Louda et al. 2003; Schick et al. 1996; Wajnberg et al. 2001).Some have concluded that biological control regulation is archaic and Strong and Pemberton(2001) stated that in the United States “In the absence of reform, rational as well as irrationalopposition to biological control will grow. Only sensible reform will maintain public sup-port for this powerful tool.” There is now a growing consensus that all deliberate introduc-tions of non-indigenous species should be subject to impact risk assessment (Wittenberg andCock 2001). Furthermore, regulations for biological control agents “... are needed to provideclear guidance as to what introduction can be made legally and to define procedures to resolveany conflicts of interest that may arise.” (Van Driesche and Bellows 1996). As Mason andKuhlmann (2002) concluded, it is clear that regulations for biological control agents are nec-



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essary not only for the preservation of biodiversity but for the protection of biological con-trol as a pest management strategy. Messing (2000) suggested that regulations would alsohelp allay some of the concerns about introductions of exotic species that result in exagger-ated estimation of the risks in doing so. The challenge is how legislation can facilitate ratherthan impede entomophagous biological control.

EXISTING REGULATIONS

Regulation of entomophagous biological control agents varies greatly around the world fromjurisdictions where there is no regulation to those where specific laws have been enacted andare strictly enforced. Others (e.g., Barratt et al. 2003; Hoddle 2003) summarized the status ofbiological control regulations up to 2002. Since then, new developments have taken place andthese will be outlined as they pertain to entomophagous biological control activities in NorthAmerica. Of particular note are the combined efforts to harmonize the information require-ments for submissions to regulatory agencies for approval to release biological control agents.

INTERNATIONAL

Globally, the International Plant Protection Convention (IPPC) provides guidance for “se-curing common and effective action to prevent the spread and introduction of pests of plantsand plant products and to promote appropriate measures for their control” (FAO 1999). A‘Code of Conduct for the Import and Release of Exotic Biological Control Agents’ (FAO1996) and recently updated (Nowell 2005) serves as a framework for regional and nationalplant protection organizations to develop guidelines/regulations that are appropriate for theirjurisdiction. Under this International Standard for Phytosanitary Measures (ISPM No. 3)regional plant protection organizations, such as the North American Plant Protection Orga-nization (NAPPO), are charged with ensuring that appropriate measures are implementedand that proper documentation of movement of biological control agents is made.

Recently, an OECD initiative resulted in the document “Guidance for InformationRequirements for Regulation of Invertebrates as Biological Control Agents (IBCAs)” (OECD2004). This document purports to harmonize data requirements to enable the use of the samedata in the approval process among member countries. The OECD document is intendedprimarily for commercial biological control agents. Such harmonized regulations, by lessen-ing registration requirements amongst members, would minimize costs for developing newagents. While the detailed information requirements set out in the document are helpful,there is concern that in some areas the requirements may be impossible to meet. This isespecially the case for risk assessment where the methodologies are largely experimental. It isclearly stated in both the FAO and OECD documents that individual jurisdictions (i.e., coun-tries and their states) may require more detailed information than outlined in the Codes, tomeet their own regulations.

North America, Canada, Mexico and the United States do not regulate entomophagousbiological control agents under specific biological control acts. Rather, each country regu-lates these agents under one or more legislative acts, the primary one being a plant protectionact.


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CANADA

Biological control agents in Canada have been regulated through the Plant Protection Act(PPA) of 1990 (Department of Justice Canada 2005) which is administered by the CanadianFood Inspection Agency (CFIA). In accordance with this Act, an import permit is requiredfor importations of all exotic arthropods into Canada. Conditions attached to the permitmay include such restrictions as ‘for experimental use in a containment facility only’. Permitsare generally valid for a 3-year period and are renewable. The permitting process is based onthe provision of information relating to the source, the organism and the end-use (destina-tion). Entomophagous biological control agents are regulated under the PPA with respect totheir potential to be indirectly injurious to plants, because plant pests are loosely definedunder the Act (Parker and Gill 2002). Furthermore, commercial entomophagous agents areregulated in a similar manner to classical agents and those species with a history of importa-tion without negative effects are generally admitted under permit.

For release of a classical biological control agent or a first release of a commercial bio-logical control agent submission of a petition (based on the NAPPO standard) justifying therelease is required. The petition is reviewed by experts and representatives of other agencies,including Environment Canada (EC) and the Pest Management Regulatory Agency (PMRA)and where feasible, provincial government representatives. The review is carried out througha Biological Control Review Committee (BCRC) and depending on the comments, a recom-mendation is made for or against release to the regulatory entomologists of the CFIA whoreview all the comments and make a recommendation to the Director of the Plant HealthDivision (Fig. 1). The process generally takes about 6 months from submission to notificationthat release is approved or not approved.

The process has worked very well because recommendations are based on the scientificmerit of the petition submitted, and although reviews are done mostly on a volunteer basis,these have been completed in a timely manner. A weakness of the Canadian regulatory pro-cess is the lack of public participation. Such participation may be warranted and would makethe process truly transparent, but the way to accomplish this is not clear.

MEXICO

In Mexico, the importations of biological control agents are regulated through the Plant HealthAct of the Mexican States (SARH 1980). In these regulations the Sanidad Vegetal (Ministry ofAgriculture) is mandated to authorize the introduction of exotic arthropod species or themass production of arthropods in insectaries, for use in the biological control of pests, ac-cording to requirements set out in Articles 101 and 102. As part of the importation require-ments, the organisms must be accompanied by a certificate of biological purity and a certifi-cate of origin provided by the phytosanitary authorities of the exporting country. The permitis granted for one year, and as in Canada, it is renewable.

The importer must submit an application to the General Director of Plant Health of theMinistry of Agriculture. A copy of the application is sent to the Nacional de Referencia deControl Biológico (National Center of Biological Control Reference [NCBCR]), where it isreviewed taking into account phytosanitary and environmental risks. After the review the



705

Figure 1. Canadian review process (9 steps) for import and release of new entomophagous biological controlorganisms. BCRC = Biological Control Review Committee; CFIA = Canadian Food InspectionAgency; CPQP = Centre for Plant Quarantine Pests (CFIA); EC = Environment Canada; NAPPO =North American Plant Protection Organization; PHD = Plant Health Division (CFIA); PMRA = PestManagement Regulatory Agency (adapted from and courtesy of CFIA).

Release

APPLICANT

CFIA import office receives application for permit to import + supporting documents as per NAPPO guidelines (NAPPO 2002)

Regulatory Entomologists of CPQP

Applicant notified if documents not sufficient

* Committee consists of: 1) taxonomists, ecologists, entomologists, botanists; 2) federal and provincial scientists, extension specialists, university researchers, consultants; 3) EC + PMRA. Committee varies with each submission depending on organism, host and region

Recommendation

to Director PHD, CFIA

Positive

Issue letter and permit with import conditions

Negative

Issue letter outlining reasons

Chairman, BCRC

Review by committee*

within specified time Review by Sanidad Vegetal (Mexico)

Commentsto Chair

Recommendation

to CPQP

No further

action; petitioner may do further research

1

2

3

4

5

6

7

8

9 9

10 10


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NCBCR issues the authorization or denial through an official letter from the General Direc-tor of Plant Health to the applicant (Fig. 2).

In the case of exotic agents (for classic biological control), it is essential to justify theintroduction. This includes providing information according to the NAPPO standard on thespecificity, biology and behavior of the agent, natural enemies of the biological control agent,results from other countries on the biology and implementation of the agent. For commercialbiological control agents information must be provided on the behavior, geographical distri-bution and any phytosanitary problems associated with the prey or hosts utilized for therearing; if there are any doubts, an opinion is requested from the Consejo Nacional ConsultivoFitosanitario (National Consultative Phytosanitary Advisory Group) that consists of profes-sionals from academic institutions, research and the government. The processing time is threemonths for applications for exotic biological control agents and 10 days for beneficial organ-isms, naturally present or previously introduced and established in Mexico that are mass rearedin insectaries.

UNITED STATES

In the United States, biological control agents of plant pests and noxious weeds are regulatedby Plant Protection and Quarantine (PPQ), Animal and Plant Health Inspection Service(APHIS) of the USDA (USDA) under the Plant Protection Act of 2000 (APHIS 2005a). Thisrecently enacted legislation provides APHIS the authority to regulate organisms that maydirectly or indirectly harm plants or plant products. Unlike the previous Federal Plant PestAct of 1957, the Plant Protection Act also broadly defines biological control agents and rec-ognizes their potential to control plant pests. APHIS is authorized to regulate the importa-tion, interstate movement and environmental release of biological control agents, but mayderegulate the interstate movement and environmental release of those agents that APHIS hasdetermined not to be plant pests. APHIS is now in the process of revising its regulations tofully implement this new Act and the following discussion only describes the current regula-tory processes for the movement and release of entomophagous biological control agents thatwere developed under the older Federal Plant Pest Act.

For classical biological control research endeavors involving entomophagous agents,PPQ requires separate permits for importation to containment facilities, domestic movementto other containment facilities, and release to the environment (APHIS 2005b). In general, allmovements of entomophagous agents originating from outside the United States are assumedto actually or potentially pose some risk to plants (e.g., pest host contaminants, hyperpara-sites, unevaluated impacts on plant communities, etc.) or to nontarget species, including en-dangered or threatened species. Permits for all movements are consequently restricted toFederally inspected containment facilities to prevent the irretrievable release of the organismsto the environment. The permits for containment facilities are issued to facilitate the removalof contaminants from foreign sources, to confirm the identity and purity of the agents, and todevelop documentation that can be used to support future applications for release to the en-vironment (i.e., release from containment). We do not anticipate changes to this approachwhen new regulations are proposed under the Plant Protection Act.



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Figure 2. Steps for import and release biological control organisms in Mexico. NCBCR = National Center ofBiological Control Reference. NCCPG= National Consultative Phytosanitary Advisory Group.

Recommendation

Issue

authorization and recommendations

together with an official letter signed

by the General Director of

Plant Health

Issue denial to

import and recommendations together with an

official letter signed by the General

Director of Plant Health,

Including details of the reasons

for the denial

If there are doubts consultation is made with the Committee of Biological Control of the NCPAG consisting of: Academic Professionals Research Professionals Government Professionals

The decision is sent to the interested parties

Note: 1. To carry out the importation, the applicant has the responsibility to send a copy of

the certificates of origin and biological purity, as well as information about the actual activities after the importation to the NCBCR.

2. If the applicant doesn't send the information indicated in the previous note, the next application to import biological control agents will be refused until the requested requirements are fulfilled.

Application by the importer to the General Director of Sanidad Vegetal.

The NCCBR receives a copy of the import application, addressing the requirements set out in Articles 101 and 102 of the Plant Health Act, and additional

supporting technical information.

2’3

1

6

54

22


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Following processing of agents and conducting basic biological studies (including hostspecificity evaluations) in containment, researchers may submit an application to PPQ forenvironmental release. A supporting document must accompany the application with infor-mation equivalent to the NAPPO petition discussed in the Canadian process. PPQ will re-view the supporting documentation and may request additional reviews with input by Cana-dian and Mexican counterparts to make a decision on whether or not the agent can be safelyreleased to the environment. Decisions are made based on anticipated indirect or direct plantpest risks including potential impacts on nontarget species, especially endangered and threat-ened species. Any potential impacts on endangered and threatened species would trigger theEndangered Species Act of 1973 and would require consultation with the United States Fishand Wildlife Service in the Department of Interior. If PPQ determines that the release of theagent will not likely result in adverse impacts to plants and/or nontarget species, a determina-tion of no further regulatory jurisdiction is documented on the permit application and sentback to the applicant. Otherwise the application is denied. When a determination of nojurisdiction is made, the agent may be moved and released throughout the contiguous UnitedStates without PPQ permits. Federal permits are still required for movements to and releasesin Hawaii, Alaska, Guam, Puerto Rico, American Samoa, and the U.S. Virgin Islands. WhenPPQ makes a determination of no jurisdiction, individual States may require their own per-mits under State laws and regulations. This current regulatory process for environmentalrelease of entomophagous agents does not trigger the National Environmental Policy Act of1972 (NEPA), and no formal environmental assessments are produced to document thesedeterminations of no jurisdiction (technically no Federal permit is issued). However, allsubsequent Federal actions, including releases by Federal employees, on Federal lands, orunder Federal funding may require compliance with NEPA. We anticipate that PPQ willbegin issuing permits for release of entomophagous agents with new regulations under thePlant Protection Act. Such a change will require PPQ to develop formal environmental as-sessments to document for the public record the information used to make the Federal deci-sion. However, the information currently provided as part of the NAPPO decision is largelywhat is required to develop a more formal environmental assessment. In addition, we antici-pate that PPQ will begin requiring permits for the domestic movement of all entomophagousbiological control agents except those formally deregulated by an official listing in the FederalRegister. Listing will require an environmental assessment as well as a continuing safetyrecord following establishment in broad areas of the United States.

PPQ permits are required for the importation of entomophagous biological control agentscommercially produced outside the United States, including in Canada and Mexico. Com-mercial import permits restrict the species allowed entry to those agents that are indigenousto and widely distributed in the contiguous United States. All such imports are received andinspected at PPQ inspection stations where identity and purity are evaluated. The inspectionprocess confirms the absence of plant pest risk and Federal permits are not required for sub-sequent movements within the contiguous United States. As with research releases, Statepermits may be required for releases in individual states. Equivalently, commercial move-ments and releases of domestically produced entomophagous biological control agents withinthe contiguous United States do not require PPQ permits as long as the shipments containonly approved indigenous species and are clear of plant pest host materials and other con-



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taminants (e.g., hyperparasites). As with research releases, we anticipate that PPQ will beginrequiring permits for the domestic movement of all entomophagous biological control agentsexcept those that are formally listed as deregulated.

It is apparent that in the U.S., several levels of regulations apply to entomophagousbiological control agents. As Messing (2000; 2005) has stated, establishment of clear, coher-ent, and streamlined regulations at the national level will be important to ensuring objectiveassessment of the risks and benefits of biological control in the U.S.

HARMONIZATION

In North America, there has been important progress in harmonizing the data required forrelease of entomophagous biological control agents. Petitions submitted to the regulatoryagencies (CFIA, APHIS and Sanidad Vegetal) must conform to the standards set out in theNAPPO guidelines (NAPPO 2002). These guidelines were developed by representatives ofCanada, Mexico and the United States and are a first attempt to harmonize the data require-ments for the three countries. In the case of entomophagous biological control agents theNAPPO guidelines are dynamic and can be changed with the advent of new knowledge.

ARE THESE REGULATIONS AND THEIR OVERSIGHT APPROPRIATE FOR BIOLOGICALCONTROL AGENTS?

The key to ensuring that arthropod biological control agents are appropriately assessed willbe the expertise of the agency (or agencies) in each country that oversees regulation. Depend-ing on the agency mandated with this responsibility, requirements and risk assessments couldbe based on models used for pesticides (as is the case for microbial agents) or even humanpathogens. For entomophagous biological control agents, the most appropriate regulatorymodels are those already in place for regulating classical biological control agents of weeds. InNorth America these models are based on ecological theory and assessments are done mainlyby scientific experts reporting to regulatory agencies. In addition, they are linked to IPPCstandards and thus are in step with regulation of biological control agents in other jurisdic-tions.

In the context of plant protection, biological control agents are either direct (phytopha-gous) or indirect (entomophagous) plant pests depending on trophic relationships and thepest status of the associated plant (Fig. 3). Herbivores that feed on weeds are considered to bebeneficial plant pests as are natural enemies of herbivores that feed on native endangered and/or important plant species. Similar patterns are apparent for pollinators and decomposers.The biological relationships at each trophic level remain the same regardless of whether theplant is a weed, native species or crop. Because of these complex relationships regulation ofentomophagous biological control agents would thus be most appropriate under plant pro-tection acts.

The entomophagous biological control agents that have come under the regulationsoutlined above are beginning to be carefully scrutinized. For example, based on petitionsreviewed in Canada, 64% (7/11) of the biological control agents recommended by the BCRCand CFIA regulatory entomologists have been approved for release since 2000. Those sub-missions that were not approved were for agents for which host specificity could not be dem-


Mason et al. __________________________________________________________________________________

710onstrated or for targets for which a native North American species might be more suitable forbiological control. The arguments in support of release have been based on scientific studiesand have been peer reviewed. Turnaround from the time of petition submission until ap-proval or rejection of the agent for release is six months.

There are several limitations to the current system in North America. There is a per-ceived lack of transparency of the approval process. Public input is not yet incorporated intothe review of petitions, nor is it a required part of the justification for initiating biologicalcontrol projects. Reviews should incorporate comments from all interested parties in all threecountries.

Another shortcoming of the current process is the availability of appropriate methodol-ogy for assessing impacts of entomophagous biological control agents. Risk assessment isusually interpreted as meaning the greater the specificity of a biological control agent, the lessthe risk for non-target impacts. However, for arthropod biological control agents, host speci-ficity testing has lagged behind that for weed biological control agents because historicallythe concerns for non-target impacts on invertebrates has not been as great (Waage 2001).Furthermore, the shear complexity of raising arthropods for testing has created a researchbottleneck. Historical published data and collections continue to be an important source ofhost range determinations. Protocols used for assessing host range of weed biological controlagents are well-defined but these are not necessarily appropriate for entomophagous biologi-cal control agents (Barratt et al. 1999; Kuhlmann et al. 2000; Mason et al. 1999; Sands 1998).However, biological control researchers are actively developing appropriate protocols (Bigleret al. 2006; Van Dreische and Reardon 2004). The NAPPO guidelines used in North Americaare flexible in terms of the detail of host range data that are required for a petition for release

Figure 3. Pest status of trophic groups associated with ‘valued’ and ‘non-valued’ (=weed) plants. Shadedboxes indicate ‘pest’ groups.

Weed

Pollinators

Natural Enemies

Herbivores Decomposers

Natural Enemies

Natural Enemies

Hyperparasites

Plant

Pollinators

Natural Enemies

Herbivores Decomposers

Natural Enemies

Natural Enemies

Hyperparasites

Plant Pests



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of an entomophagous biological control agent. This flexibility was intended to facilitate con-tinued release of safe agents while screening methods and interpretation of results are beingdeveloped. As this knowledge becomes more sophisticated, the guidelines can be updated.

COMPLIANCE

A major challenge for regulation of entomophagous biological control agents is to ensurecompliance on the part of biological control practitioners. The present process relies on anhonour system where submissions are made voluntarily by ethical individuals/agencies. Likeinspection of international shipments and detection of inappropriate commodities, ensuringthat all entomophagous biological control agents released are approved may be impossible.The best strategy to promote compliance will be timely review of submissions and fair assess-ments.

CONCLUSIONS

Increased regulation of entomophagous biological control agents in North America is inevi-table. While no comprehensive legislation such as a ‘Biocontrol Act’ exists in Canada, Mexicoor the United States, exotic invertebrates imported for release as biological control agents arebeing regulated under existing plant protection and associated acts. As demonstrated by theregulatory processes in Canada and Mexico, review of submissions for release of entomopha-gous biological control agents is timely and scientifically based. This encourages complianceby practitioners and safety of the agents based on best available knowledge. While the futureof using entomophagous biological control agents will be that of greater scrutiny, appropri-ate legislation and regulation will ensure continuing effectiveness and increased safety.

ACKNOWLEDGEMENTS

The authors thank Doug Parker and Joe Vorgetts for critical comment on the manuscript.

REFERENCES

APHIS 2005a. Overview of Plant Pest and Noxious Weeds Permitting Process. http://www.aphis.usda.gov/ppq/permits/overview.html (last accessed Apr. 4 2005).

APHIS 2005b. Agricultural Permits, Predators and Parasitoids of Arthropods. http://www.aphis.usda.gov/ppq/permits/biological/predators.html (last accessed Apr. 4 2005).

Barratt, B. I. P., Ferguson, C. M., McNeill, M. R., and Goldson, S. L. 1999. Parasitoid HostSpecificity Testing to Predict Field Host Range. In “Host Specificity Testing inAustralasia: Towards Improved Assays for Biological Control” (T. M. Withers, L.Barton Browne, and J. Stanbley, Eds.), pp. 70-83. CRC for Tropical Pest Management,Brisbane Australia.


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Barratt, B. I. P., Cullen, J. M., Moeed, A., and Rose, A. 2003. Legal Issues SurroundingImportation of Natural Enemies. In “Proceedings of the International Symposium onBiological Control of Arthropods” Honolulu, Hawaii, 14-18 January 2002” (R. G. VanDriesche, Ed.), p. 40. USDA Forest Service, Morgantown, West Virginia.

Bigler, F., Babendreier, D., and Kuhlmann, U. (Eds.) 2006. “Environmental Impact ofInvertebrates for Biological Control of Arthropods: Methods and Risk Assessment,”CABI Publishing, Wallingford Oxon (in press).

Bright, C. 1999: Invasive species: pathogens of globalization. Foreign Policy 116, 50-64.

Department of Justice Canada. 2005. The Plant Protection Act 1990, c.22. http://laws.justice.gc.ca./en/P-14.8/index.html (last accessed Apr. 6 2005)

FAO. 1996. “International Standards for Phytosanitary Measures, Part 1. Import Regula-tions, Code of conduct for the Import and Release of Exotic Biological Control Agents”.Secretariat of the International Plant Protection Convention, FAO, Rome Italy.

FAO. 1999. “International Plant Protection Convention”. Food and Agriculture Organiza-tion of the United Nations, Rome.

Follett, P. A., and Duan, J. J. (Eds.). 2000. “Nontarget Effects of Biological Control,”Kluwer Academic Publishers, Norwell Massachusetts, U.S.A.

Hoddle, M. S. 2003. Classical Biological Control of Arthropods in the 21st Century. In“Proceedings of the International Symposium on Biological Control of Arthropods.Honolulu, Hawaii, 14-18 January 2002” (R. G. Van Driesche, Ed.), pp. 3-16. USDAForest Service, Morgantown, West Virginia.

Howarth, F. G. 1991. Environmental impacts of classical biological control. Annual Re-view of Entomology 36, 485-509.

Kuhlmann, U., Mason, P. G., and Foottit, R. G. 2000. Host Specificity Assessment ofEuropean Peristenus Parasitoids for Classical Biological Control of Native Lygus speciesin North America: Use of Field Host Surveys to Predict Natural Enemy Habitat andHost Ranges. In “Proceedings of Session: Host Specificity Testing of Exotic ArthropodBiological Control Agents - The Biological Basis for Improvement in Safety” (R. G. VanDriesche, T., Heard, A., McClay, and R. Reardon, Eds.), pp. 84-95. USDA, ForestHealth Technology Enterprise Team, Morgantown West Virginia.

Louda, S. M., Arnett, A. E., Rand, T. A., and Russell, F. L. 2003. Invasiveness of somebiological control insects and adequacy of their ecological risk assessment and regulation.Conservation Biology 17, 73-82.

Mason, P. G., and Kuhlmann, U. 2002. Regulations are necessary for biological controlagents. IOBC/wprs Bulletin 25, 165-171.

Mason, P. G., Foottit, R. G., and Kuhlmann, U. 1999. Practical use of systematic and eco-logical analyses to determine non-target species for host-range testing of entomophagousbiological control agents. IOBC/ WPRS Bulletin 22, 43.



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Messing, R. 2000. The Impact of Nontarget Concerns on the Practice of Biological Con-trol. In “Nontarget Effectsof Biological Control” (P. A. Follett, and J. J. Duan, Eds.), pp.45-55. Kluwer Academic Publishers, Norwell Massachusetts, U.S.A.

Messing, R. 2005. Hawaii as a Role Model for Comprehensive U.S. Legislation: The Bestand the Worst of it. In “Proceedings, 2nd International Symposium of Biological Controlof Arthropods” 12-16 September 2005, Davos, Switzerland (M. S. Hoddle, Ed.), (thisissue).

NAPPO. 2002. Guidelines for Petition for Release of Exotic Entomophagous Agents forthe Biological Control of Pests (RSPM # 12). http://www.nappo.org/Standards/OLDSTDS/RSPM12-e.pdf (last accessed Mar. 23 2005)

Nowell, D. 2005. International guidelines for the export, shipment, import and release ofbiological control agents and other beneficial organisims (ISPM No. 3). In “Proceedings,2nd International Symposium of Biological Control of Arthropods” 12-16 September2005, Davos, Switzerland (M. S. Hoddle, Ed.), (this issue)

OECD. 2004. Guidance for Information Requirements for Regulation of Invertebrates asBiological Control Agents (IBCAs). OECD Series on Pesticides, Number 21. http://www.oecd.org/dataoecd/6/20/28725175.pdf (last accessed Mar. 19 2005)

Parker, D. J. and Gill, B. D. 2002: Invasive Species and Biological Control. In “BiologicalControl Programmes in Canada 1981-2000” (P. G. Mason, and J. T. Huber, Eds.), pp 1-4. CABI Publishing, Wallingford, Oxon, U.K.

Sands, D. P. A. 1998: Guidelines for testing host specificity of agents for biological cojntrolof arthropod pests. Sixth Australiasian Applied Entomological Research Conference,The University of Queenslad, Brisbane, Australia Volume 1, 556-560.

Schick, K., Eliason, E. A., Whittaker, P., Chenot, A., Riehle, M. and Voss, K. 1996: TheUnited States Has Been Negligent in Regulating the Importation, Release, and Use ofGeneralist Natural Enemies. In “Environmental Issues Associated with Enhancing theImpact of Biological Control Agents: A Student Debate” (F. Gould, G. Kennedy, and R.Kopanic, Eds.), pp 161-164. American Entomologist 42.

Secretaría de Agricultura y Recursos Hidraúlicos. 1980. Reglamento de la Ley de SanidadFitopecuaria de los Estados Unidos Mexicanos, en Materia de Sanidad Vegetal. DirecciónGeneral de Sanidad Vegetal. In “18 de Enero de 1980, Diario Oficial-Organo delGobierno Constitucional de los Estados Unidos Mexicanos”, pp. 33-34.

Simberloff, D. 1992: Conservation of Pristine Habitats and Unintended Side Effects ofBiological Control. In “Selection Criteria and Ecological Cnsequemces of ImportingNatural Enemies” (W. C. Kauffman and J. E. Nechols, Eds.), pp. 103-117. Proceedings,Thomas Say Publications in Entomology, Entomological Society of America, Lanham,Maryland, U.S.A.


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Strong, D. R., and Pemberton, R. W. 2001: Food Webs, Risks of Alien Enemies and Re-form of Biological Control. In “Evaluating Indirect Ecological Effects of BiologicalControl” (E. Wajnberg, J. K. Scott, and P.C. Quimby, Eds.), pp. 57-79. CABI Publish-ing, Wallingford, Oxon, U.K.

Van Dreische, R. G. and Reardon, R. (Eds.). 2004. “Assessing Host Ranges for Parasitoidsand Predators Used For Classical Biological Control: A Guide to Best Practice”. USDA,Forest Health Technology Enterprise Team, Morgantown, West Virginia, U.S.A.

Van Driesche, R. G. and Bellows, T. S Jr. 1996. “Biological Control,” Chapman and Hall,New York, New York, U.S.A.

Waage, J. K. 2001: Indirect Ecological Effects in Biological Control: The Challenge and theOpportunity. In “Evaluating Indirect Ecological Effects of Biological Control” (E.Wajnberg, J. K. Scott and P. C. Quimby, Eds.), pp. 1-12. CABI Publishing, Wallingford,Oxon, U.K.

Wajnberg, E., Scott, J. K. and Quimby, P. C. (Eds.). 2001. “Evaluating Indirect EcologicalEffects of Biological Control,” CABI Publishing, Wallingford, Oxon, U.K.

Wittenberg, R. and Cock, M. J. W. (Eds.). 2001. “Invasive Alien Species: A Toolkit of BestPrevention and Management Practices,” CAB International, Wallingford, Oxon, U.K.

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REGULATION OF THE RELEASE OF BIOLOGICAL CONTROLAGENTS OF ARTHOPODS IN NEW ZEALAND AND AUSTRALIA

Libby HARRISON1, Abdul MOEED 1, and Andy SHEPPARD2

1Environmental Risk Management AuthorityP.O. Box 131

Wellington, New [email protected]

2 CSIRO European LaboratoryCampus de Baillarguet

34980 Montferrier-sur-Lez, [email protected]

ABSTRACT

Regulation of biological control agents in New Zealand is legislated by the Hazardous Sub-stances and New Organisms (HSNO) Act 1996 and administered by the Environmental RiskManagement Authority (ERMA New Zealand). In Australia the Department of the Environ-ment and Heritage and the Agriculture Fisheries and Forestry Australia - Australian Quaran-tine Inspection Service jointly regulate the import, testing and release of biological controlagents under the Quarantine Act 1908, Wildlife Protection (Regulation of Exports and Im-ports) Act 1982 and Biological Control Act 1984. A comparison of the two regulatory sys-tems highlights the pivotal role of information from the host-specificity testing in the deci-sion making process and the valuable opportunity for researchers to interact with the public.

INTRODUCTION

Historically, releases of exotic biological control agents and associated regulations were withinthe framework of quarantine and plant protection legislation managed through agriculturalauthorities. However, an increasing public understanding and concern for the environmenttowards the end of the 20th century brought environmental issues associated with such re-leases to the fore along with an increasing involvement of environmental authorities. Parallelto this, environmental legislation being implemented around the world following the Con-vention on Biological Diversity (CBD) Decision VI/23 in 1992 on “alien species that threatenecosystems, habitats or species”, designed to protect against such invasions, adopts the ‘pre-cautionary approach’ within it. This has in turn has led to increasingly precautionary atti-tudes towards classical biological control releases.

The legislative risk assessment process for biological control agents prior to permissionsbeing granted for release has therefore increased in scope and also complexity in most coun-tries as the regulatory responsibilities for releasing exotic organisms now equally concernboth agriculture (the traditional arena) and the natural environment. Similarly proposed re-


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leases of genetically modified organisms (GMOs) have also instigated general concerns aboutreleasing novel genotypes into the environment along with increased awareness of criticalissues in ecological risk analysis of such introductions recognized internationally through theCartagena Protocol on Biosafety. Finally international plant protection legislation has alsoadopted policy in relation to biological control releases. The International Plant ProtectionConvention (IPPC) Code of Conduct for the Import and Release of Exotic Biological Con-trol Agents and its recent updates are an illustration of this. It is within this context that wereview the current regulations for biological control agent releases in New Zealand and Aus-tralia comparing attitude to risks as well as procedural differences.

REGULATION OF BIOLOGICAL CONTROL AGENTS IN NEW ZEALAND

The introduction of biological control agents (BCA) into New Zealand is regulated under theHSNO Act by ERMA New Zealand. Practitioners of biological control may apply for ‘con-tainment approval’ to import a BCA for host-specificity testing followed by a ‘full releaseapproval’ when they wish to release the agent. Applications are assessed in accordance withthe purpose of the Act which “is to protect the environment, and the health and safety ofpeople and communities, by preventing or managing the adverse effects of …new organ-isms”. This is done by taking into account the following matters identified in the Act:

i. Sustainability of native and valued introduced flora and faunaii. The intrinsic value of ecosystemsiii.Public healthiv.The culture and traditions of Mâori (indigenous people)v. Market economyvi.International obligations

ERMA New Zealand is an ‘autonomous’ crown entity, partially funded by governmentthat reports to the Minister for the Environment and is overseen by the Ministry for theEnvironment. Under the Crown entities legislation, ERMA New Zealand must have regardto government policy when directed by the Minister for the Environment but importantly,statute provides that the Minister may not give a direction that relates to the exercise of itscore decision making powers to consider or grant approvals. ERMA New Zealand is com-posed of three parts; the Agency, the Authority and the Mâori Advisory Committee. TheAgency works directly with applicants to facilitate submission of, and process applicationsbut the decision making power resides with the Authority. The Authority is a quasi-judicialbody1 of 6-8 people appointed by the Minister for the Environment who are selected to rep-resent a ‘balanced mix of knowledge and experience in matters likely to come before theAuthority’2 so may or may not have a scientific background. In making their decision theAuthority undertakes a risk, cost, benefit (RCB) analysis using a consistent methodologyprescribed by regulation in 19983.

1 Under the HSNO Act they have the same immunities and privileges of High Court judges when undertaking their coredecision making powers and the power to operate under ‘court-like’ procedure ie to permit cross-examinations or ques-tions of clarification.

2 Section 16 of the HSNO Act.3 The Hazardous Substances and New Organisms (Methodology) Order 1998.



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In the case of a full release application this RCB is done on information provided by theapplicant, submissions (these may be received from members of the public, government de-partments, industry and community groups), the Agency and, where relevant, external ex-perts and the Mâori Advisory Committee. Figure 1 summarises the application process for afull release application for which the applicant is charged NZ$30,000. It should be noted thatin addition to obtaining an ERMA New Zealand approval applicants must also obtain anImport Permit under the Biosecurity Act 1993 from the Ministry of Agriculture and Forestry(MAF). MAF is responsible for New Zealand’s Import Health Standards (IHS) designed toprevent accidental or illegal introductions of viable organisms (in this case associated organ-isms such as pathogens).

Figure 1. A diagrammatic representation of the application process for the full release of a biological controlagent in New Zealand.


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REGULATION OF BIOLOGICAL CONTROL AGENTS IN AUSTRALIA

Introduction of BCAs is regulated by two departments the Department of Agriculture, Fish-eries and Forestry – Biosecurity Australia (DAFF-BA) and the Department of the Environ-ment and Heritage (DEH) under three pieces of legislation:

i. the Quarantine Act (1908)ii. Biological Control Act (1984)iii.Environment Protection and Biodiversity Conservation Act (1992)

DAFF-BA is responsible for managing risks to primary industries and agriculture whilstthe DEH is responsible for managing risks to the environment. Approvals are issued andimplemented by the Department of Agriculture, Fisheries and Forestry – Australian Quaran-tine Inspection Service (AQIS).

The Australian process for arthropod targets is similar to that for weed targets and is allencompassing with four major steps to the process as summarised in Figure 2 and listed be-low:

1. A potential BCA is identified and approval is sought to import into containment.

2. Application submitted for acceptance of list of species against which the potential agentwill be tested for specificity

3. Application submitted to release biological control agent

4. The applicant reports on BCA establishment, efficacy and any non-target effects.

The Australian process currently allows for two phases of public comment through theDEH; one phase prior to importation when terms of reference for the assessment of likelyimpacts of the agent on the environment and one phase with respect to the draft release appli-cation through the DEH web site (Sheppard et al. 2003). Following this the final assessmentis tabled in Parliament to allow comment from government departments. The final decisionto release is made by the relevant Minister on the advice of the associated department. Ap-proval may be reviewed within 5 years of approval.

Australia operates biological control within a formal legislative acceptance of its ben-efits under the Biological Control Act (1984) (Cullen and Delfosse 1985). This Act itself wasset up to assist in the resolution of conflicts of interest by allowing for public consultationsand enquiries, but is rarely used in practice as biological control projects with significantconflicts of interest rarely eventuate (Sheppard et al. 2003). No biological control projectagainst an arthropod pest has ever been scrutinized under the Act.

COMPARISON OF THE TWO SYSTEMS

Table 1 summarises some of the key components of the systems. A comparison of the twosystems reveal that there are some key differences in the way in which this ‘guidance’ has beenimplemented (Table 1).



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PROCESS SCOPE

The entire process from importation of potential BCA through to host-specificity testing andeventual release is regulated in Australia. In New Zealand only the import into containmentfor host-specificity testing and subsequently the release is regulated, with the applicant deter-mining how host-specificity testing is done. While the New Zealand process provides the

Abbreviations: AQIS - Australian Quarantine and Inspection Service BA - Biosecurity Australia DAFF - Australian Government Department of Agriculture, Fisheries and Forestry DEH – Australian Government Department of Environment and Heritage

Application submitted to AQIS

Biosecurity Australia (BA)

1. Import

- research purposes - high security quarantine facilities - BA and DEH assessment only

2. Host-specificity test list

- distribute application to 21 cooperators - allow 40 working days for response - BA coodinates responses - BA and DEH assess application as cooperators- Assume no objections if no response - BA notified by cooperator(s) when issue(s) are resolved between applicants and cooperators who did not support the test list initially

3. Release

- distribute application to 21 cooperators - allow 40 working days for response - BA coodinates responses - BA also assesses application as cooperator - Assume no objections if no response - BA notified by cooperator(s) when issue(s) are resolved between applicants and cooperators who did not support the release initially - DEH assesses application under EPBC Act

DEH approved DEH testing

permit

BA recommends approval AQIS import permit

All responses supporting the list and/or issue(s) resolved between applicant and cooperator(s)

All responses supporting the release and/or issue(s) resolved between applicant and cooperator(s)

DEH approved DEH letter of

approval

BA recommends approval AQIS letter of approval

BA recommends approval AQIS letter of approval

Figure 2. DAFF and DEH protocol for biological control agent applications. Note that application for importand for release will need to be submitted to both AQIS and DEH separately; application for hosspecificity test list only needs to be submitted to AQIS. Credit: Australian Government, Departmentof Agriculture, Fisheries and Forestry, http://www.affa.gove.au; retrieved April 18, 2005.


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720applicant with more autonomy, the Australian process would seem to avoid the risk errors/omissions in the host-specificity testing as it is regulated. For example, a decision on a recentapplication for full release of a weed BCA in New Zealand was delayed over a year as theAuthority were concerned that the applicant had failed to include key species in the host-specificity testing. The Agency is attempting to avoid this happening again by making poten-tial applicants more aware of the importance of adequate host-specificity testing. In the pastNew Zealand applications have relied heavily on host-specificity testing data from overseasand the regulation of host-specificity testing means this would not be an option in the Aus-tralian system.

PUBLIC PARTICIPATION

The New Zealand system has a unique feature where any person may make a submission ona publicly notified application4 and request a public hearing into the application. While hear-ings may be viewed by the applicant as an obstacle, this is the only opportunity for the appli-cant to discuss in person their application with the decision-makers. This interaction has inthe past provided a valuable forum for clarification of issues that have contributed to positiveoutcomes for applicants. Submitters also comment favourably on having the opportunity to‘be heard’. In an article discussing regulation of genetically modified organisms in New Zealand,which is also covered under the HSNO Act, Herrera (2005) noted that the public participa-tion “gives New Zealanders more power to participate in the approval process...than anyother people in the world.” Holding a public hearing remains a practical option in New Zealanddue to the comparatively small population and limited geographical area. It is anticipated that

Table 1. Comparative analysis of the key components of the New Zealand and Australian regulatorysystems.

Component New Zealand Australia

Process scope Regulates import into containmentand release but not host-specificitytesting.

Regulates import into containment,host-specificity testing and release.

Public participation viaa hearing

Occurs if requested (has happened inevery case to-date).

Only if the agent is declared under theBiological Control Act (neverhappened for an agent proposedagainst an arthropod).

RCB analysis scope Includes direct and indirect effects. Limited to direct effects.

Risk averseness Risk neutral or averse. Risk neutral or accepting (at present).

Decision-maker Quasi-judicial body and notnecessarily government employees orscientists.

Minister for the Environment andHeritage and the Chief PlantProtection Officer.

Post approval activities None - organism is no-longer 'new' sois not subject to HSNO regulation.

Post-release monitoring ofestablishment, efficacy, and non-targeteffects is required but not enforced.

4 All full release applications must be publicly notified whereas applications to import new organisms into containment areonly publicly notified if the Agency considers that there will be significant public interest in the application.



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attempting to hold such a hearing in Australia would be a significantly larger and more costlyundertaking. However, the Australian public do have an opportunity to comment on appli-cations in a written form.

SCOPE OF EFFECTS CONSIDERED IN THE RCB ANALYSIS

In a review of regulators worldwide Sheppard et al. (2003) noted that “currently only theNew Zealand approach closely matches a full ecological risk-benefit-cost analysis”. This isprobably a reflection of the fact that the HSNO Act requires a wider range of effects to beconsidered beyond the biophysical as demonstrated in the following two case studies. Fur-thermore, there is also some acceptance of a quantitative approach to risk-benefit analysisconducted by the Authority, for example in economic analyses of potential savings of insec-ticides.

In Australia the process still reflects a historical bias that biological control releases arelargely beneficial, the decision-makers being somewhat risk accepting to risk neutral in atti-tude. As a result, beyond evaluating the potential risks to non-target species, there is no for-mal requirement for an extensive evaluation of potential benefits or secondary indirect effectsof BCA. That means the Australian system does not follow as clearly a formalised RCB analysisapproach as that adopted in New Zealand.

New Zealand Case Study. Pseudococcus viburni or obscure mealybug is a pest of pipfruitwith its presence resulting in the formation of sooty mould which can result in fruit beingunsaleable. In 2000 the release of the parasitoid Pseudaphycus maculipennis (Mercet) (Hy-menoptera, Encyrtidae) (Fig. 3) was approved as a biologicalcontrol agent of Pseudococcus viburni (Maskell) (Hemiptera,Pseudococcidae).

The Authority considered the most important potentialadverse effect associated with approving this application tobe parasitism of native mealybugs. This concern was in rela-tion to a particular endemic mealybug but it was also pointedout that because of the incomplete knowledge of the nativefauna, there was a potential for effects on as yet undescribedspecies. If this adverse effect was realised this would have flow-on effects to Mâori culture.

The Authority considered the most significant poten-tial benefit of approving the application to be reducing theapplication of organophosphates, which would subsequently reduce:

• Insecticide residues in soil

• Impacts on human health through residues on food, spray drift and occupational expo-sure to insecticides

• A reduction in adverse effects of insecticides to native insects with flow-on cultural ben-efits to Mâori

Figure 3. Pseudaphycus maculipennis.Photo: Shaun Forgie,HortResearch. UGA1390027


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• A reduction in adverse effects of insecticides to beneficial insects with flow-on benefits tointegrated pest management of apples systems

• A reduction in the development of insecticide resistance.

The Authority also noted the economic gains to the horticultural industry via directsavings in insecticide applications, and improved sustainability.

Australian Case Study. In 2004 the release of Eretmocerus hayati (Zolnerowich and Rose)(Hymenoptera, Aphelinidae) (Fig. 4) a parasitoid for the control of Bemisia tabaci (silverleafwhitefly) was approved.

Bemisia tabaci (Gennadius) (Homoptera, Aleyrodidae) isa pest of ornamental nursery crops, vegetables and cotton caus-ing feeding damage and reducing quality through the forma-tion of sooty mould.

A summary of the potential impacts on the Australianenvironment noted that the results of host-specificity testing“predicts an extremely narrow host range”. It also stated that“the risk to non-target whitefly is extremely low”, particularlywhen compared to the risk of the widespread use of pesticides.

The discussion of the benefits in the application waslimited to recognising that the amount of insecticide appliedagainst the pest has “reduced the profitability of growers andhas threatened the viability of existing low pesticide inputmanagement strategies”.

RISK AVERSENESSInherent in the New Zealand legislation is a need for the decision-maker to consider indirectimpacts. Due to the wide scope of the risk assessment (as previously discussed) and becausethere is no mechanism for compensation to affected parties, the New Zealand decision-mak-ers are likely to be risk averse. In comparison, the Australian system provides for compensa-tion of individuals exposed to adverse effects and so decision-makers are likely to be riskaccepting or risk neutral.

DECISION-MAKER

In New Zealand the focus has been to select decision-makers that are experts in a wide rangeof fields to better represent the opinion of the general New Zealand public:

• Retired Foreign Diplomat• Professor of Chemistry• Hazardous Substances Advisor to public sector groups• Senior Lecturer in Mâori• Senior Scientist of Insect Ecology• Associate Professor of Molecular Biology• Senior Scientist of Molecular Biology• Partner in a law firm

Figure 4. Eretmocerus hayati.Photo: CSIROEntomology.UGA1390028



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Advice on scientific, cultural, ethical and economic issues is provided by the Agency orrelevant external experts. All documentation has to be produced in a manner that is also ac-cessible to a lay audience. In Australia there is a reliance on scientific experts and staff in theMinisters office to aid the Minister in making a decision. This means that in New Zealandthere is a degree of separation from the politics of the day which is in contrast to the Austra-lian system where Ministers may be lobbied by special interest or industry groups. Althoughthe New Zealand Authority is not completely removed from the influence of the politicalarena as has been previously mentioned, members are appointed by the Minister. It should benoted that in New Zealand there are limited grounds of appeal in relation to the merits of anapplication, however, given the quasi-judicial nature of the Authority the High court canundertake a judicial review of administrative decision-making. In its decision-making theAuthority is required to take into account the need for caution in managing adverse effectswhere there is scientific and technical uncertainty about those risks.

In Australia the decision can be challenged through the courts. In such a case, however,the agency that made the releases can apply to have the biocontrol agent declared under theBiological Control Act. To achieve this, a public enquiry is required and the outcome must bea clear demonstration that the benefits of releasing the agent clearly out-weigh the risks. Oncethe agent is declared under the Act the agency responsible for the release is legally protectedfrom indemnity. Not surprisingly certain agencies have requested the Act be simplified sothat all agents can be declared under it prior to release. However, this would require a majorrevision of the Act and so has not occurred. In practise biological control projects with sig-nificant conflicts of interest are no longer undertaken.

POST APPROVAL ACTIVITIES

In a continuation of the more holistic approach of the Australian system, applicants are re-quired to submit a report to AQIS 12 months after release of the BCA regarding establish-ment, efficacy and any non-target effects. As the full release approvals granted in New Zealandhave no associated controls post-release monitoring is not regulated, but is often encouraged.Recent changes to the HSNO Act have introduced a new category of approval, ‘conditionalrelease’, which differs from full release in that controls can be placed on approvals for thepurposes of mitigating risk, including but not limited to the following:

• Controlling the extent and purposes for which organisms could be used

• Requiring any monitoring, auditing, reporting, and record-keeping

• Compliance with relevant codes of practice or standards

• Development of contingency plans to manage potential incidents

• Limiting the dissemination or persistence of the organism or its genetic material in theenvironment

• Requiring the disposal of any organisms or genetic material

• Limiting the proximity of the organism to other organisms

• Setting requirements for any material derived from the organism


Harrison et al. ________________________________________________________________________________

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• Imposing obligations on the approval user (e.g., training, number of approval users)

• Specifying the duration of the approval

The requirement for controls that ‘mitigate risks’ associated with an individual approval pre-sents challenges for decision-makers wanting assurances regarding the outcomes of an ap-proval. Conditional release provides an opportunity for decision-makers to limit importa-tions of BCA to the same geographical location from which individuals for testing were col-lected, hence mitigating the risk of non-target effects due to ‘ecotype’ differences. While notapplicable to the parasitoid scenario, conditional release could allow for pre-release monitor-ing of effects using sterilised BCA.

FUTURE CHALLENGES AND OPPORTUNITIES

The challenges that the regulation of BCA present to researchers in the field are immediateand obvious. Concerns about the additional costs and time associated with gaining regulatoryapproval has resulted in an additional obstacle to the scientific community. However, partici-pation in the regulatory system presents many opportunities for researchers beyond the ob-vious attainment of approval. Key to both the New Zealand and Australian system of regulat-ing BCA is the results of host-specificity testing. Having to provide assurances to regulatorsthat adverse effects are unlikely to occur has challenged researchers to ensure that testingprotocols are robust and sound. This has generated opportunities for investigating the princi-pals and practices of host-specificity testing. In Australia this is part of the regulatory systemand ERMA New Zealand is also taking a pro-active role in promoting and supporting re-search in this area by acting as partner in a recent successful bid by experts for governmentresearch funding. The regulatory system provides an opportunity for peer review of host-specificity testing to ensure rigour and accuracy of results, particularly in the Australian sys-tem. In New Zealand, this process takes place, but only after the application has been re-ceived.

Both the New Zealand and Australian systems provide researchers with an invaluableopportunity to interact with members of the public. Applicants can use the process as anavenue to achieve public education of a science the benefits of which are poorly understood.A recent report released in New Zealand has demonstrated the value of this kind of interac-tion in enhancing a more positive image in the public perception of science. When discussingthe issue of human biotechnology (HBT) researchers found that in discussion groups whichdid not include scientists, the attitudes of members of the public “towards scientists becamemore negative and they grow more concerned about HBT. On the other hand, when engagedin dialogue with scientists, their attitudes became more positive towards scientists and HBT,they had more empathy with scientists, and they had less concern about HBT” (Roper et al.2004).

In conclusion, while it would initially appear that the regulation of biological controlagents present obstacles to researchers, if applied constructively it may have the potential toprovide other benefits beyond ensuring the release of efficacious agents that will cause mini-mal adverse side effects.



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DISCLAIMER

The views presented in this publication are those of the authors and not necessarily theiremployer.

ACKNOWLEDGEMENTS

The authors would like to thank Dr Sonia Whiteman for helping to prepare the paper.

REFERENCES

Herrera, S. 2005. New Zealand: Green Haven for Biotech? From TechnologyReveiw.com:http://www.technologyreview.com/articles/05/02/issue/brief_newzealand.asp?p=0 (lastaccessed April 15 2005).

Roper, J. R., Zorn, T., and Weaver, C. K. 2005. Science Dialogues. The CommunicativeProperties of Science and Technology Dialogue. A project for the Ministry of Research,Science and Technology December 2004. Produced by the Department of ManagementCommunication, University of Waikato.

Sheppard, A. W., Hill, R., DeClerck-Floate, R. A., McClay, A., Olckers, T., Quimby, P.C., and Zimmermann, H. G. 2003. A global review of risk-benefit-cost analysis for theintroduction of classical biological control agents against weeds: a crisis in the making?Biocontrol News and Information 24, 91N-108N.


Nowell and Maynard __________________________________________________________________________

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INTERNATIONAL GUIDELINES FOR THE EXPORT, SHIPMENT,IMPORT, AND RELEASE OF BIOLOGICAL CONTROL AGENTS

AND OTHER BENEFICIAL ORGANISMS (INTERNATIONALSTANDARD FOR PHYTOSANITARY MEASURES NO. 3)

David C. NOWELL1 and Glynn V. MAYNARD2

1IPPC Secretariat, FAO-AGPPvialle delle Terme di Caracalla

0100 Rome, [email protected]

2Department of Agriculture, Fisheries and ForestryGPO Box 858

Canberra, ACT, 2601 [email protected]

ABSTRACT

This paper describes the development and review of the International Standard forPhytosanitary Measures (ISPM No. 3) which provides guidelines for risk management relat-ing to the export, shipment, import and release of biological control agents and other benefi-cial organisms. The standard lists the related responsibilities of contracting parties to the In-ternational Plant Protection Convention (IPPC) (‘contracting parties’), of National Plant Pro-tection Organizations (NPPOs) or of other responsible authorities, importers and exporters.ISPM No. 3 addresses biological control agents capable of self-replication (including parasi-toids, predators, parasites, nematodes, phytophagous organisms, and pathogens such as fungi,bacteria and viruses), sterile insects and other beneficial organisms (such as mycorrhizae andpollinators), including those packaged or formulated as commercial products. Provisions arealso included for importation of non-indigenous biological control agents and other benefi-cial organisms for research in quarantine facilities.

INTRODUCTION

Phytosanitary standards (ISPMs) are developed under the auspices of the International PlantProtection Convention (IPPC) and provide a framework within which national plant protec-tion organisations (NPPOs) can develop regulations to provide for plant protection. Thelevel of phytosanitary protection that is considered appropriate for any given country, is forthat particular country to decide. The finalization and adoption of the IPPC occurred afterthe first publication of ISPM No. 3 (FAO 1996b). In the 1980’s onwards there was an increas-ing volume (both number of species and number of individual specimens) of biological con-trol agents moved internationally, particularly classical biological control agents and those

__________________ International Guidelines for Transportation and Release of Biological Control Agents


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used for inundative release. Prior to 1995, there was no agreed international guidance for thetrans-boundary movement of these live organisms, hence FAO developed ISPM No. 3 toaddress a specific need. It was decided that the most appropriate place for such an interna-tional guideline was within the framework of the IPPC. The FAO Conference adopted ISPMNo. 3 in 1995, before the revision of the IPPC (which was adopted in 1997) and the finaliza-tion of the World Trade Agreement on the Application of Sanitary and Phytosanitary Mea-sures. There have also been many scientific developments in the knowledge of biological con-trol agents since 1995. It is within this context that ISPM No. 3 was developed and now beenrevised.

The primary support standard to ISPM No. 3 was ISPM No. 2 (FAO 1996a). Moredetailed guidance on Pest Risk Analysis is provided in other ISPMs, particularly ISPM No.11 (FAO 2004a) and ISPM No. 21 (FAO 2004c).

At the second session of the ICPM (October 1999) issues wider than agriculture, such asthe impact on the environment and other relevant international agreements, were consideredin the context of the IPPC (e.g., the Convention on Biological Diversity). The ICPM estab-lished an expert working group to consider this and other relevant issues. An output of theworking group was that the recommendation that ISPM No. 3 be amended “to include con-sideration of risk of spread of biological control organisms to other countries”.

Prior to revision, the scope of ISPM No. 3 was relatively narrow and primarily appli-cable to classical biological control agents. Although conceptually it encompassed the prin-ciples of the IPPC and SPS Agreement and could in practice be applied more widely, it wasnot explicit on a number of important phytosanitary issues e.g. pest risk analysis. Therefore,the scope of ISPM No. 3 was broadened to encompass the principles and articles of IPPC, inparticular Article VII 2 (g) “Contracting parties may make provisions, with adequate safe-guards, for the importation for purposes of scientific research or education, of plants and plantproducts and of specimens of plant pests. Adequate safeguards likewise need to be taken whenintroducing biological control agents and organisms claimed to be beneficial.” Hence the re-vised standard has incorporated guidelines that cover other beneficial organisms with par-ticular reference to sterile insects as well as biological control agents.

In addition, ISPM No. 3 was considered by the ICPM for possible review in 2001 (fiveyears after adoption, as is standard for all adopted ISPMs) and issues such as the rapid in-crease in the use of, and trade in biological control agents, as well as developments in biologi-cal control practices meant there was a need to update this standard. The standard also neededto be made consistent with other more recently developed ISPMs and phytosanitary conceptswithin the framework of the IPPC. The revision of ISPM No. 3 was placed on the IPPCwork programme and the revision commenced as soon as funding became available.

REVIEW OF ISPM NO. 3

Given the above context and to ensure that all relevant issues were addressed in this process,the ICPM Standards Committee drafted specifications for the review of ISPM No. 3. Ac-cording to IPPC Specification No. 4 the review needed to include the consideration of:



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• Revision of title and text;

• Pest risk analysis procedures appropriate for biological control agents;

• Regulatory guidance developed by the OECD since publication of the standard;

• Issues relating to the transport and handling of biological control agents;

• Possibilities for clarification and emphasis with regards to invasive species and otherimpacts on the environment, and

• Issues relating to pre and post release monitoring.

Other matters to be considered and addressed where appropriate were:

• Sterile insect technique (SIT) issues;

• Beneficial organism issues, and

• The use of biological control agents that had been genetically modified using modernbiotechnology techniques.

An expert working group (including nine independent experts plus the IPPC Secre-tariat) met in December 2003 at FAO Headquarters in Rome to revise ISPM No. 3. Theoutcome was a revised draft ISPM No. 3 that was reviewed by the Standards Committee inMay 2004. The draft ISPM No. 3 was released for country consultation in June 2004. Manycomments were received and all comments from all interested parties had to channel theircomments through the NPPOs. Comments provided by the NPPOs were considered by theStandards Committee and the necessary adjustments made to the draft. The final version ofthe standard was submitted to the seventh session of the ICPM (in April 2005) for consider-ation. After minor modifications it was adopted as ISPM No. 3 (FAO 2005a and 2005c).

The Standard states that it is “intended to facilitate the safe export, shipment, import andrelease of biological control agents and other beneficial organisms. Responsibilities relating tothis are held by contracting parties, NPPOs or other responsible authorities, and by importersand exporters.” However it does not include reference to living modified organisms, issuesrelated to registration of biopesticides, or microbial agents intended for vertebrate pest con-trol.

“Contracting parties, or their designated authorities, should consider and implementappropriate phytosanitary measures related to the export, shipment, import and re-lease of biological control agents and other beneficial organisms and, when neces-sary, issue related import permits.”

As described in this standard, NPPOs or other responsible authorities should:

• “Carry out pest risk analysis of biological control agents and other beneficial organ-isms prior to import or prior to release;

• Ensure, when certifying exports, that the phytosanitary import requirements of im-porting contracting parties are complied with;



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• Obtain, provide and assess documentation as appropriate, relevant to the export,shipment, import or release of biological control agents and other beneficial organ-isms;

• Ensure that biological control agents and other beneficial organisms are taken ei-ther directly to designated quarantine facilities or mass-rearing facilities or, if ap-propriate, passed directly for release into the environment;

• Encourage monitoring of release of biological control agents or beneficial organismsin order to assess impact on target and non target organisms.

Responsibilities of, and recommendations for, exporters include ensuring that con-signments of biological control agents and other beneficial organisms comply withphytosanitary import requirements of importing countries and relevant internationalagreements, packaging consignments securely, and providing appropriate documen-tation relating to biological control agents or other beneficial organisms.

Responsibilities of, and recommendations for, importers include providing appropri-ate documentation relating to the target pest(s) and biological control agent or otherbeneficial organisms to the NPPO or other responsible authority of the importingcountry.”

DISCUSSION

A primary objective of the revision of ISPM No. 3 was to ensure consistency with the IPPC(FAO 1997) and that it was harmonized with relevant IPPC phytosanitary terms (FAO 2005b).

OBJECTIVES OF THE STANDARD

The objectives of the standard are to:

• “Facilitate the safe export, shipment, import and release of biological control agentsand other beneficial organisms by providing guidelines for all public and privatebodies involved, particularly through the development of national legislation whereit does not exist;

• Describe the need for cooperation between importing and exporting countries sothat:

i. benefits to be derived from using biological control agents or other beneficialorganisms are achieved with minimal adverse effects;

ii.practices which ensure efficient and safe use while minimizing environmentalrisks due to improper handling or use are promoted.”

Guidelines in support of these objectives are described that:

• “Encourage responsible trade practices

• Assist countries to design regulations to address the safe handling, assessment anduse of biological control agents and other beneficial organisms



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• Provide risk management recommendations for the safe export, shipment, importand release of biological control agents and other beneficial organisms

• Promote the safe use of biological control agents and other beneficial organisms.”

SCOPE OF THE IPPC

The International Plant Protection Convention (IPPC) is based on securing common andeffective action to prevent the spread and introduction of pests of plants and plant products,and the promotion of appropriate measures for their control. In this context, the provisionsof the IPPC extend to any organism capable of harbouring or spreading plant pests, particu-larly where international transportation is involved (Article I of the IPPC, 1997). A pest isdefined as “any species, strain or biotype of plant, animal or pathogenic agent injurious toplants or plant products”.

The IPPC (1997) contains the following provision in relation to the regulation of bio-logical control agents and other beneficial organisms. Article VII.1 states:

“With the aim of preventing the introduction and/or spread of regulated pests intotheir territories, contracting parties shall have sovereign authority to regulate, in ac-cordance with applicable international agreements, the entry of plants and plant prod-ucts and other regulated articles and, to this end, may:

d) prohibit or restrict the movement of biological control agents and other organismsof phytosanitary concern claimed to be beneficial into their territories.”

Section 4.1 of ISPM No. 20 (FAO 2004b) contains a reference to the regulation of bio-logical control agents; it states:

“Imported commodities that may be regulated include articles that may be infestedor contaminated with regulated pests. ... The following are examples of regulatedarticles: ... pests and biological control agents.”

The revised ISPM No. 3 provides international guidelines relating to phytosanitarymeasures, as well as recommending guidelines for the safe use of biological control agents andother beneficial organisms claimed to beneficial. Phytosanitary concerns with regards to bio-logical control agents include the possibility that newly introduced biological control agents,or organisms claimed to be beneficial may introduce pests or diseases which affect the agent,hence reduce the effect of a biological control program or may severely disrupt an existingbiological control program; or may significantly affect non-target organisms, such that thereare harmful effects on plant species or plant health. This standard does not alter in any waythe scope or obligations of the IPPC itself as contained in the New Revised Text (1997) orconflict with any of the other ISPMs.

Most of the standard is based on the premise that a biological control agent or otherbeneficial organism may be a potential pest itself, and in this sense Article VII.1c of the IPPC(1997) applies because contracting parties may prohibit or restrict the movement of regulatedpests into their territories. In some situations, biological control agents and other beneficialorganisms may act as a carrier or pathway for plant pests, hyperparasitoids, hyperparasites



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and entomopathogens. In this sense, biological control agents and other beneficial organismsmay be considered to be regulated articles as described in Article VII.1 of the IPPC (1997)and ISPM No. 20 (FAO 2004b).

ISPM No. 3 does not specifically cover genetically modified organisms (GMOs). Al-though GMOs are specifically excluded, the principles of pest risk analysis for assessment ofrisk and implementation of an appropriate level of protection are still applicable. In addition,this standard does not cover pesticide registration. Pesticide registration is an independent setof processes that differ between countries. The extent to which organisms covered in ISPMNo.3 are involved in these registration processes depends on individual countries. In someinstances the processes and information required are coincident with the requirements ofISPM No.3. However, the objectives of pesticide registration are different as a whole fromthose of the IPPC/ISPM No.3, although there may be similar elements.

STRUCTURE

The structure of this revised standard broadly follows that of the original ISPM No. 3, and itscontent is based primarily on risk management relating to the use of biological control agentsand other beneficial organisms. Based on in-country experience, the previous format of ISPMNo. 3 was very easy to understand and popular in the field, and so as much of the content andformat as possible was retained.

PEST RISK ANALYSIS

The existing standards on pest risk analysis (ISPM No. 2 (FAO 1996a), ISPM No. 11 (FAO2004a) and ISPM No. 21 (FAO 2004c)) provide the appropriate fundamental processes forcarrying out pest risk assessments for biological control agents and other beneficial organ-isms. In particular, ISPM No. 11 includes provisions for pest risk assessment in relation toenvironmental risks, and this aspect covers environmental concerns related to the use of bio-logical control agents. Implicit in the development of the output of a risk analysis is the devel-opment of risk management plans for organisms being considered.

The IPPC (1997) takes into account internationally approved principles governing theprotection of the environment (Preamble). Its purpose includes promoting appropriatephytosanitary measures (Article I.1). Therefore, in carrying out pest risk analyses in accor-dance with this and other appropriate ISPMs, and in developing and applying relatedphytosanitary measures (i.e., pest risk management), contracting parties should consider thepotential for broader environmental impacts resulting from releasing biological control agentsand other beneficial organisms (e.g., the impact on non-target invertebrates).

ISSUES/CHANGES

The content of ISPM No. 3 was not consistent with that of more recent ISPMs in that itincluded a significant amount of technical implementation details, as well as having a signifi-cantly different functional layout and terminology (e.g., see Table 1 for a summary of termi-nology changes). The revision removed the technical details and adjusted the layout of thetext to align more closely with that of other standards.



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Table 1. A summary of ISPM No. 3 terminology changes.

Term New Modified Deleted

Authority x

Beneficial Organism x

Biological Control x

Biological Control Agent x

Biological Pesticide (biopesticide) x

Classical Biological Control Agent x

Contamination x

Control (of a pest) x

Ecoarea x

Entry (of a consignment) x

Establishment x

Exotic x

Import Permit (of a biological control agent) x

Host Range x

Infestation (of a commodity) x

Introduction x

Inundative Release x

Natural Enemy x

Organism x

Parasitoid x

Pathogen x

Phytosanitary Measure x

Quarantine x

Reference Specimens x

Regulated Organism x

Specificity x

Sterile Insect x

Sterile Insect Technique x

It is recognized that much of the information removed was useful to various partiesinvolved in the practical processes of import and release of biological control agents and otherorganisms claimed to be beneficial. It is intended that the technical implementation detailswill be compiled into a set of technical explanatory documents in support of the standard.These documents will not be obligatory, have no official status under the ICPM, and will notbe considered official interpretations of ISPM No. 3. However, they may provide examples



733

of processes and methodologies that could be followed when implementing the standard.According to the ICPM, such explanatory documents need to be developed under the aus-pices of the IPPC secretariat (otherwise they do not have ISPM explanatory document sta-tus).

The general arrangement of ISPM No. 3 (FAO 2005a) is as follows: “designation ofresponsible authority and description of general responsibilities; pest risk analysis; responsi-bilities of contracting parties prior to import, documentary responsibilities of importer priorto import; responsibilities of exporter; responsibilities of NPPO or other responsible author-ity of the importing contracting party upon import; responsibility of the NPPO or otherresponsible authority before, upon and following release.

The implementation of the guidelines is the responsibility of the contracting parties (usu-ally the NPPO’s) or other responsible authorities. Previously, ISPM No. 3 included detailsand obligations for organisations (e.g., exporters, researchers and importers) that are beyondthe scope of the IPPC.

These guidelines are not legally binding under the IPPC, but are indirectly bindingthrough the WTO/SPS Agreement. Advice for parties other than NPPOs, such as exporters,is provided. This advice is for guidance on appropriate process and is not obligatory. Theobligations of non-NPPO parties are those contained in the regulations of countries withinwhich they operate. These regulations should have been developed by the NPPO within theframework of ISPM No.3, hence align with the ISPMs objectives.

Reference is made to other international agreements were appropriate, but such refer-ences are intentionally vague to ensure it is not implied the IPPC is infringing or interpretingsuch agreements.

The revision of ISPM No. 3 should improve the understanding of the processes associ-ated with the import and release of biological control agents and/or beneficial organisms, andfacilitate the safe trade in such organisms while protecting the environment. This ISPM con-tinues to provide a framework for countries to establish their own phytosanitary measuresfor biological control agents and/or beneficial organisms i.e., it is not a prescriptive standardthat details phytosanitary measures that should be applied in all countries around the world.

Further information on ISPM No. 3 (or any other ISPM or the IPPC) can be obtainedfrom the IPPC Secretariat ([email protected]) or: IPPC Secretariat, FAO-AGPP, Vialle delle Termedi Caracalla, 00100 Rome, Italy.

ACKNOWLEDGEMENTS

The IPPC expert working group that revised ISPM No. 3 included Mr Gregory Wolff (Canada- steward), Mr Dale Meyerdirk (U.S.A.), Mr Fernando Tambasco (Brazil), Mr MbondjiMbondji (Cameroon), Ms Glynn Maynard (Australia), Mr Wai Ram Dass Gautam (India),Mr Moses Kairo (CABI), Mr Alan Robinson (FAO/IAEA), and Ms Marie-Chantal Huet(OECD). In addition, significant contributions to the revision have been made by the IPPCStandards Committee and through country comments received on the draft revision.



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REFERENCES

FAO. 1996a. ISPM No. 2: Guidelines for Pest Risk Analysis. FAO, Rome, Italy.

FAO. 1996b. ISPM No. 3: Code of Conduct for the Import and Release of Exotic Biologi-cal Control Agents. FAO, Rome, Italy.

FAO. 1997. International Plant Protection Convention. FAO, Rome, Italy.

FAO. 2004a. ISPM No. 11: Pest Risk Analysis for Quarantine Pests Including Analysis ofEnvironmental Risks and Living Modified Organisms. FAO, Rome, Italy.

FAO. 2004b. ISPM No. 20: Guidelines for a Phytosanitary Import Regulatory System.FAO, Rome, Italy.

FAO. 2004c. ISPM # 21: Pest Risk Analysis for Regulated Non-Quarantine Pests. FAO.Rome, Italy

FAO. 2005a. ISPM No. 3: Guidelines for the Export, Shipment, Import and Release ofBiological Control Agents and Other Beneficial Organisms, 2005, FAO, Rome, Italy.

FAO. 2005b. ISPM No. 5: Glossary of Phytosanitary Terms. FAO, Rome, Italy.

FAO. 2005c. Report of the Seventh Session of the Interim Commission on PhytosanitaryMeasures. FAO, Rome, Italy.

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